FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Memantine Merz 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: Memantine Merz memantine hydrochloride
Maltese: Memantine Merz memantina idroklorika
English: The most common side effects with Memantine Merz (seen in between 1 and 10 patients in 100) are somnolence (sleepiness), dizziness, balance disorders, hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, headache, raised liver function test results and drug hypersensitivity (allergy to the medicine).
Maltese: L-effetti sekondarji l-iktar komuni bl-użu ta' Memantine Merz (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma somnolenza, sturdament, disturbi fil-bilanċ, ipertensjoni (pressjoni għolja tad-demm), dispnea (diffikultà fit-teħid tan-nifs), stitikezza, uġigħ ta' ras, riżultati ogħla waqt it-testijiet tal-fwied u ipersensittività għall-mediċina.
English: It is available as tablets (5 mg, 10 mg, 15 mg and 20 mg).
Maltese: Jiġi f'pilloli (5 mg, 10 mg, 15 mg u 20 mg). Memantine Merz huwa disponibbli wkoll bħala soluzzjoni orali, mogħtija permezz ta' pompa li tagħti 5 mg ta' memantina idroklorika ma' kull attivazzjoni.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Memantine Merz on 22 November 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Memantine Merz fit-22 ta' Novembru/Diċembru 2012.
English: The active substance in Memantine Merz, memantine hydrochloride, is an antidementia medicine.
Maltese: Is-sustanza attiva f'Memantine Merz, il-memantina idroklorika, hija mediċina kontra d-dimenzja.
English: This summary was last updated in November 2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Novembru 2012.
English: This is a summary of the European public assessment report (EPAR) for Memantine Merz.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Memantine Merz.
English: Memantine Merz is used to treat patients with moderate to severe Alzheimer's disease.
Maltese: Memantine Merz jintuża fil-kura ta' pazjenti morda bl-Alzheimer minn stat moderat sa gravi.
English: Memantine Merz is a medicine that contains the active substance memantine hydrochloride.
Maltese: Memantine Merz huwa mediċina li fih is-sustanza attiva memantina kloridrat.
English: Memantine Merz was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Maltese: Memantine Merz ġie studjat ukoll fi tliet studji supplimentari li b'kollox fihom ħadu sehem 1,186 pazjent bil-marda fi stadju ħafif jew gravi.
English: Memantine Merz has been studied in three main studies including a total of 1,125 patients with Alzheimer's disease, some of whom had taken other medicines for their disease in the past.
Maltese: Memantine Merz ġie studjat fi tliet studji prinċipali li b'kollox ħadu sehem fihom 1,125 pazjent bilmarda ta' Alzheimer.
English: What is Memantine Merz?
Maltese: X'inhu Memantine Merz?
English: The company that makes Axura has agreed that its scientific data can be used for Memantine Merz (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Axura qablet li d-dejta xjentifika tagħha tista' tintuża għal Memantine Merz (“kunsens infurmat”).
English: Memantine Merz was more effective than placebo at controlling the symptoms of Alzheimer's disease.
Maltese: Memantine Merz kien iktar effikaċi mill-plaċebo fil-kontroll tas-sintomi tal-marda ta' Alzheimer.
English: The first study involved 252 patients with moderately severe to severe disease, while the other two involved a total of 873 patients with mild to moderate disease.
Maltese: L-ewwel studju involva 252 pazjent bil-marda ta' Alzheimer moderata sa gravi, mentri t-tnejn l-oħra b'kollox involvew 873 pazjent bil-marda fi stadju minn ħafif sa moderat. Memantine Merz tqabbel ma' plaċebo (trattament finta) tul 24 sa 28 ġimgħa.
English: The main measures of effectiveness were the change in symptoms in three main areas: functional (the degree of disability), cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fis-sintomi fi tliet oqsma prinċipali: funzjonali (il-grad ta' diżabbiltà), konjittiv (il-kapaċità tal-ħsieb, it-tagħlim u lmemorja) u globali (kombinazzjoni ta' diversi oqsma inklużi l-funzjoni ġenerali, is-sintomi konjittivi, limġiba u l-kapaċità li wieħed iwettaq l-attivitajiet ta' kuljum).
English: In the study of moderately severe to severe disease, patients taking Memantine Merz had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
Maltese: Flistudju fejn il-marda kienet moderata sa gravi, il-pazjenti li ħadu Memantine Merz kellhom inqas sintomi minn dawk li ħadu plaċebo wara 28 ġimgħa, kif ġie mkejjel kemm b'punteġġ globali kif ukoll funzjonali.
English: Why has Memantine Merz been approved?
Maltese: Għaliex ġie approvat Memantine Merz?
English: What is the risk associated with Memantine Merz?
Maltese: Għal xiex jintuża Memantine Merz?
English: In the two studies of mild to moderate disease, patients on Memantine Merz had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
Maltese: Fiż-żewġ studji fejn il-marda kienet fi stadju ħafif sa moderat, wara 24 ġimgħa l-pazjenti li ngħataw Memantine Merz kellhom sintomi inqas gravi, skont kif imkejjel fil-punteġġ globali u konjittiv.
English: To prevent side effects, the dose of Memantine Merz is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Maltese: Biex jiġu evitati effetti sekondarji, id-doża ta' Memantine Merz tiżdied bil-mod il-mod matul l-ewwel tliet ġimgħat tat-trattament: fl-ewwel ġimgħa d-doża tkun 5 mg; fit-tieni ġimgħa titla' għal 10 mg; u fit-tielet ġimgħa ssir 15 mg.
English: For the full list of all side effects reported with Memantine Merz, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Memantine Merz ara l-fuljett ta' tagħrif.
English: Other information about Memantine Merz
Maltese: Tagħrif ieħor fuq about Memantine Merz
English: How has Memantine Merz been studied?
Maltese: Kif ġie studjat Memantine Merz?
English: This medicine is the same as Axura, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal Axura, li hija diġà awtorizzata fl-Unjoni Ewropea (UE).
English: Memantine Merz must not be used in people who are hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients.
Maltese: Memantine Merz ma għandux jintuża minn persuni li huma ipersensittivi (allerġiċi) għall-memantina idroklorika jew għal kwalunkwe sustanza oħra tiegħu.
English: Common (> 1/100 and < 1/10): frequent bowel movements, flatulence.
Maltese: Komuni (> 1/100 u < 1/10): moviment frekwenti tal-imsaren, gass.
English: Diacerein is not recommended in patients older than 65 years.
Maltese: Diacerein mhuwiex irrakkomandat f'pazjenti li għandhom aktar minn 65 sena.
English: - increase in liver enzymes levels in blood tests.
Maltese: Każijiet ta' enzimi epatiċi elevati fis-serum.
English: Elevated serum hepatic enzyme levels and symptomatic acute hepatic injury have been reported with diacerein in the post-marketing phase (see section 4.8).
Maltese: Ġew irrapportati livelli elevati ta' enzimi tal-fwied fis-serum u ħsara epatika akuta sintomatika b'diacerein fil-fażi ta' wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: HEPATOBILIARY DISORDERS
Maltese: GASTRO-INTESTINALI
English: Very common (> 1/10): diarrhoea, abdominal pain.
Maltese: Komuni ħafna (> 1/10): dijarea, uġigħ addominali.
English: Caution must be exercised in the concomitant administration of diuretics (high-ceiling loop and thiazides) and/or cardiac glycosides (digitoxin, digoxin), as the risk of arrhythmia is increased (see section 4.4).
Maltese: Wieħed għandu joqgħod attent fl-għoti flistess ħin ta' dijuretiċi (loop u tijażidi b'limitu għoli) u/jew glikosidi kardijaċi (digitoxin, digoxin), peress li jkun hemm riskju akbar ta' arritmija (ara sezzjoni 4.4).
English: As some patients may experience loose stools or diarrhoea, the recommended starting dose is 50 mg once daily with evening meal for the first 2 to 4 weeks of treatment, after which the recommended daily dose is 50mg twice daily.
Maltese: Peress li xi pazjenti jafu jesperjenzaw ippurgar maħlul jew dijarea, id-doża inizjali rakkomandata hija ta' 50 mg darba kuljum mal-ikla ta' filgħaxija għall-ewwel ġimagħtejn sa 4 ġimgħat ta' kura, u wara, id-doża ta' kuljum irrakkomandata hija ta' 50 mg darbtejn kuljum.
English: [The following side effects should be inserted in this paragraph] Common side effects (may affect up to 1 in 10 people treated): - frequent bowel movements, - flatulence - pruritus (itching), rash, eczema (itchy, red rash).
Maltese: [Għandhom jiddaħħlu l-effetti sekondarji li ġejjin f'dan il-paragrafu] Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10 ikkurati): - moviment tal-imsaren frekwenti, - gass - ħakk, raxx, ekżema (bil-ħakk, raxx aħmar).
English: Hepatotoxicity
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Particular caution should also be exercised in case of hypokalaemia in patients treated with cardiac glycosides (digitoxin, digoxin) (see section 4.5).
Maltese: Għandha wkoll tiġi eżerċitata kawtela partikolari f'każ ta' ipokalemija f'pazjenti kkurati b'glikosidi kardijaċi (digitoxin, digoxin) (ara sezzjoni 4.5).
English: Contraindications
Maltese: Epatotossiċità
English: Common (> 1/100 and < 1/10): pruritus, rash, eczema.
Maltese: TA' TAĦT IL-ĠILDA Komuni (> 1/100 u < 1/10): ħakk, raxx, ekżema.
English: In some cases, diarrhoea was severe with complications such as dehydration and disorders of fluid and electrolyte balance.
Maltese: F'xi każijiet, id-dijarea kienet severa b'kumplikazzjonijiet bħal deidrazzjoni u disturbi ta' bilanċ ta' fluwidu u tal-elettroliti.
English: SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Maltese: FIL-ĠILDA U FIT-TESSUTI
English: Cases of acute liver injury, including elevated serum hepatic enzymes and cases of hepatitis have been reported in the post-marketing phase with diacerein.
Maltese: Ġew irrapportati każijiet ta' ħsara akuta fil-fwied, inkluż ammont elevat ta' enzimi tal-fwied fis-serum u każijiet ta' epatite fil-fażi ta' wara t-tqegħid fis-suq b'diacerein.
English: Treatment with [Invented Name] is therefore not recommended for a specific form of hip osteoarthritis called rapidly progressive (worsening) hip osteoarthritis.
Maltese: Għalhekk, il-kura b'[Isem Ivvintat] mhijiex irrakkomandata għal forma speċifika ta' osteoartrite tal-ġenbejn imsejħa osteoartrite talġenbejn bi progressjoni (aggravar) rapida.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Maltese: Anness III Emendi għas-sezzjonijiet relevanti tas-sommarju tal-karatteristiċi tal prodott u fuljetti ta' tagħrif
English: [The following wording should be reflected in this section]
Maltese: [Il-formulazzjoni ta' kliem li ġejja għandha tiġi riflessa f'din is-sezzjoni]
English: Intake of diacerein frequently leads to diarrhoea (see section 4.8) that can consequently lead to dehydration and hypokalaemia.
Maltese: It-teħid ta' diacerein b'mod frekwenti jwassal għal dijarea (ara sezzjoni 4.8) li konsegwentement jista' jwassal għal deidrazzjoni u ipokalimja.
English: Posology
Maltese: DISTURBI
English: [The following wording should also be reflected in this section] Diacerein is not recommended in patients older than 65 years.
Maltese: [Il-formulazzjoni ta' kliem li ġejja għandha tiġi ukoll riflessa f'din is-sezzjoni] Diacerein mhuwiex rakkomandat f'pazjenti li għandhom iktar minn 65 sena.
English: [The following wording should be reflected in this section] It is recommended that you start treatment with one capsule in the evening for the first 2-4 weeks, after which the dose can be increased to two capsules per day.
Maltese: [Il-formulazzjoni ta' kliem li ġejja għandha tiġi riflessa f'din is-sezzjoni] Huwa rrakkomandat li tibda l-kura b'kapsula waħda filgħaxija għall-ewwel 2-4 ġimgħat, u wara, iddoża tista' tiżdied għal żewġ kapsuli kuljum.
English: Other medicines and [Invented Name] [The following wording should be reflected in this section] Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Maltese: Mediċini oħra u [Isem Ivvintat] [Il-formulazzjoni ta' kliem li ġejja għandha tiġi riflessa f'din is-sezzjoni] Għid lit-tabib jew lill-infermier tiegħek jekk qiegħed tieħu, ħadt dan l-aħħar jew tista' tieħu xi mediċina oħra.
English: Treatment with diacerein is not recommended in patients with rapidly progressive hip osteoarthritis, as they may have a weaker response to diacerein.
Maltese: Il-kura b'diacerein mhijiex rakkomandata f'pazjenti b'osteoartrite tal-ġenbejn bi progressjoni rapida, peress li jaf ikollhom reazzjoni aktar dgħajfa għal diacerein.
English: Tell your doctor immediately if you have abdominal pain, jaundice (yellow discolouration of the eyes or skin), impaired consciousness or itching of the skin, as these may indicate serious conditions such as liver disease.
Maltese: Għid lit-tabib tiegħek immedjatament jekk ikollok uġigħ addominali, suffejra (sfurija tal-għajnejn jew il-ġilda), tintilef minn sensik jew ikollok ħakk fil-ġilda, peress li dawn jistgħu jindikaw kundizzjonijiet serji bħal mard tal-fwied.
English: As a rule, these effects abate with continuing treatment.
Maltese: Bħala regola, dawn l-effetti jitnaqqsu b'kura kontinwa.
English: MA EU Number
Maltese: Numru MA (EU)
English: Immediate Packaging
Maltese: Daqs talPakkett
English: Content Pack Size
Maltese: Il- Pakkett li jmiss malprodott
English: Further information on Alunbrig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Alunbrig.
Maltese: ema.europa.eu/medicines/human/EPAR/Alunbrig.
English: The medicine is available as tablets (30 mg, 90 mg and 180 mg).
Maltese: Il-mediċina tiġi bħala pilloli (30 mg, 90 mg u 180 mg).
English: The most common side effects with Alunbrig (which may affect more than 1 in 4 people) are hyperglycaemia (high blood sugar levels), hyperinsulinaemia (high blood insulin levels), anaemia (low red blood cell counts), nausea (feeling sick), low white blood cell counts including decreased levels of the white blood cells called lymphocytes, diarrhoea, tiredness, cough, headache, hypophosphataemia (low blood levels of phosphates), rash, vomiting, dyspnoea (difficulty breathing), hypertension (high blood pressure), myalgia (muscle pain), peripheral neuropathy (damage to the nerves in the extremities) and blood test results indicating abnormalities of liver (increased levels of ALT and AST and alkaline phosphatase), pancreas (increased lipase and amylase), muscle function (increased CPK) or blood clotting (increased APTT).
Maltese: L-effetti sekondarji l-aktar komuni b'Alunbrig (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 4) huma ipergliċemija (livelli għoljin ta' zokkor fid-demm), iperinsulinemija (livelli għoljin ta' insulina fiddemm), anemija (livelli baxxi ta' ċelloli tad-demm ħomor), nawżja (tħossok ma tiflaħx), għadd baxx ta' ċelloli tad-demm bojod inklużi livelli mnaqqsa taċ-ċelloli bojod tad-demm imsejħa limfoċiti, dijarrea, għeja, sogħla, uġigħ ta' ras, ipofosfatemija (livelli baxxi ta' fosfati fid-demm), raxx, rimettar, dispnea (diffikultà fit-teħid tan-nifs), mijalġija (uġigħ fil-muskoli), newropatija periferika (ħsara lin-nervituri flestremitajiet) u riżultati ta' testijiet tad-demm li jindikaw anormalitajiet fil-fwied (livelli għoljin ta' ALT u AST u fosfatażi alkalina), frixa (lipażi miżjuda u amilażi), funzjoni tal-muskoli (żieda tal-PK) jew ta' koagulazzjoni (żieda APTT).
English: Alunbrig contains the active substance brigatinib.
Maltese: Alunbrig fih is-sustanza attiva brigatinib.
English: What are the risks associated with Alunbrig?
Maltese: X'inhuma r-riskji assoċjati Alunbirg?
English: The active substance in Alunbrig, brigatinib, works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.
Maltese: Is-sustanza attiva f'Alunbrig, brigatinib, taħdem billi timblokka l-attività ta' ALK, b'hekk jitnaqqas it-tkabbir u t-tixrid tal-kanċer.
English: The most common serious side effects (which may affect more than 1 in 50 people) are pneumonitis (inflammation in the lungs), pneumonia (infection of the lungs) and dyspnoea.
Maltese: L-effetti sekondarji serji l-aktar komuni (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 50) huma pnewmonite (infjammazzjoni fil-pulmun), pnewmonja (infezzjoni tal-pulmun) u dispnea.
English: Out of patients who received 90 mg Alunbrig a day and increased to 180 mg after 7 days, around 56% showed a complete or partial response to the medicine.
Maltese: Mill-pazjenti li rċevew doża ta' 90 mg ta' Alunbrig kuljum u li mbagħad ġiet miżjuda għal 180 mg wara sebat ijiem, madwar 56 % irrispondew kompletament jew parzjalment għall-mediċina.
English: As for all medicines, data on the use of Alunbrig are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Alunbrig tiġi mmonitorjata kontinwament.
English: Alunbrig is a cancer medicine that is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC) who have been treated before with a cancer medicine called crizotinib.
Maltese: Alunbrig huwa mediċina kontra l-kanċer użata biex tikkura adulti b'tip ta' kanċer fil-pulmun imsejjaħ kanċer tal-pulmun mhux ta' ċellola żgħira (NSCLC - non-small-cell lung cancer), li jkunu ġew ikkurati qabel b'mediċina kontra l-kanċer imsejħa crizotinib.
English: How is Alunbrig used?
Maltese: Alunbrig?
English: ALK belongs to a family of enzymes called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them.
Maltese: ALK tagħmel parti minn familja ta' enzimi magħrufin bħala riċettur tal-kinażijiet tat-tirożina (RTKs, receptor tyrosine kinases), li huma involuti fit-tkabbir taċ-ċelloli u fl-iżvilupp ta' vażi ġodda li jfornuhom.
English: Response to treatment was assessed using body scans and standardised criteria for solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Maltese: Ir-rispons għall-kura ġie vvalutat permezz ta' skenns tal-ġisem u kriterji standardizzati użati għal tumuri solidi, u r-rispons tqies li seħħ meta lpazjent ma kien baqagħlu l-ebda sinjal tal-kanċer.
English: positive NSCLC, an abnormal form of ALK is produced that stimulates the cancer cells to divide and grow in an uncontrolled fashion.
Maltese: F'pazjenti b'NSCLC pożittiv għall-ALK, hija prodotta forma anormali ta' ALK li tistimula liċċelloli tal-kanċer biex jinqasmu u jikbru b'mod mhux ikkontrollat.
English: Other information about Alunbrig
Maltese: Informazzjoni oħra dwar Alunbrig:
English: The recommended starting dose is 90 mg taken once a day for the first 7 days and then increased to 180 mg once a day afterwards.
Maltese: Id-doża inizjali rrakkomandata hija ta' 90 mg meħuda darba kuljum għall-ewwel sebat ijiem, li mbagħad wara tiżdied għal 180 mg kuljum.
English: Alunbrig is used on its own and only if the NSCLC is ‘ALK-positive', which means that the cancer cells have certain changes affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).
Maltese: Alunbrig jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda u tiġi ssorveljata minn tabib li jkollu esperjenza fl-użu ta' mediċini kontra l-kanċer.
English: For the full list of side effects and restrictions with Alunbrig, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Alunbrig, ara l-fuljett ta' tagħrif.
English: It will also provide an alert card for patients summarising key safety information about the risk of lung disease with the medicine and what to do in case of signs and symptoms.
Maltese: Il-kumpanija għandha tipprovdi wkoll kard ta' twissija lill-pazjenti li tagħti fil-qosor l-informazzjoni prinċipali dwar is-sikurezza dwar ir-riskju ta' mard fil-pulmun meta tintuża l-mediċina u x'għandu jsir fil-każ ta' sinjali u sintomi.
English: Alunbrig was effective in treating patients with ALK-positive NSCLC previously treated with crizotinib.
Maltese: Aktar informazzjoni dwar Alunbrig tinstab fis-sit elettroniku talAġenzija:
English: 19 August 2014 EMA/515780/2014
Maltese: EMA/515780/2014
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 1 Għal aktar informazzjoni, ara hawn. 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The Linoladiol N cream (0.01 %w/w) contains 100 microgram of estradiol per gram, while Linoladiol HN (0.005 %w/w, 0.4 %w/w) contains 50 microgram of estradiol and 4 mg of the corticosteroid prednisolone per gram.
Maltese: Il-krema Linoladiol N (0.01 %w/w) fiha 100 mikrogramma ta' estradiol f'kull gramma, filwaqt li Linoladiol HN (0.005 %w/w, 0.4 %w/w) fiha 50 mikrogramma ta' estradiol u 4 mg tal-kortikosterojde prednisolone f'kull gramma.
English: Contact our press officers Monika Benstetter or Martin Harvey
Maltese: Ikkuntattja l-uffiċjali tagħna tal-istampa Monika Benstetter jew Martin Harvey
English: The CHMP issued an opinion in December 2013.
Maltese: Is-CHMP ħareġ opinjoni f'Diċembru 2013.
English: The review of the topical estradiol-containing medicines Linoladiol N and Linoladiol HN was triggered on 24 May 2012 by Germany, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni tal-mediċini topikali li fihom estradiol Linoladiol N u Linoladiol HN inbdiet fl24 ta' Mejju mill-Ġermanja, skont l-Artiklu 31 tad-Direttiva 2001/83/KE.
English: Systemic absorption of estradiol may be associated with risks similar to those seen in systemic hormone replacement therapy (HRT), including blood clots, stroke and endometrial (womb) cancer.
Maltese: Assorbiment sistemiku ta' estradiol jista' jiġi assoċjat ma' riskji simili għal dawk li jidhru f'terapija ta' sostituzzjoni tal-ormoni sistemika (HRT), inkluż emboli tad-demm, puplesija u kanċer endometrijali (fil-ġuf).
English: Linoladiol N is marketed in Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania and Slovakia, while Linoladiol HN is marketed in Estonia, Germany, Latvia and Lithuania.
Maltese: Linoladiol N qiegħed fis-suq fil-Bulgarija, fir-Repubblika Ċeka, fl-Estonja, fil-Ġermanja, fl-Ungerija, fil-Latvja, fil-Litwanja u fis-Slovakkja, filwaqt li Linoladiol HN qiegħed fis-suq fl-Estonja, filĠermanja, fil-Latvja u fil-Litwanja.
English: On 25 April 2014, the EMA's Committee for Medicinal Products for Human Use (CHMP) updated recommendations on the use of two high-strength estradiol-containing creams, Linoladiol N and Linoladiol HN.
Maltese: Fil-25 ta' April 2014, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bnedmin (CHMP) aġġorna rrakkomandazzjonijiet dwar l-użu ta' żewġ kremi li fihom estradiol b'dożi għoljin, Linoladiol N u Linoladiol HN.
English: • Linoladiol N should be applied into the vagina while Linoladiol HN should be applied to the external genital area.
Maltese: • Linoladiol N għandu jiġi applikat fil-vaġina filwaqt li Linoladiol HN għandu jiġi applikat fuq iż-żona ġenitali esterna.
English: Following a request from the company, a reexamination of the opinion for Linoladiol N was carried out and concluded in April 2014.
Maltese: Wara talba mill-kumpanija, twettqet eżaminazzjoni mill-ġdid tal-opinjoni għal Linoladiol N u din ġiet konkluża f'April 2014.