FrancophonIA/ELRC3.0 huggingface dataset:
English: The grounds for the referral was a concern raised by Spain that appropriate data had not been submitted to support a statement which was to be included in the indication for Valebo (in section 4.1 of the summary of product characteristics) that alfacalcidol reduces the rate of falls in older people.
Maltese: Ir-raġunijiet għar-riferiment kien tħassib imqajjem minn Spanja li ma kinitx ġiet ippreżentata dejta xierqa biex tappoġġa dikjarazzjoni li kellha tiġi inkluża fl-indikazzjoni għal Valebo (fis-sezzjoni 4.1 tassommarju tal-karatteristiċi tal-prodott) li alfakalċidol inaqqas ir-rata ta' waqgħat f'persuni akbar fl-età.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Valebo should be granted marketing authorisation in all concerned Member States for the treatment of postmenopausal women with osteoporosis.
Maltese: Abbażi tal-valutazzjoni tad-dejta attwalment disponibbli u d-diskussjoni xjentifika fi ħdan il-Kumitat, isCHMP ikkonkluda li Valebo għandu jingħata awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri kkonċernati kollha għall-kura ta' nisa wara l-menopawża bl-osteoporożi.
English: Alendronic acid is a bisphosphonate that has been used for osteoporosis since the mid-1990s.
Maltese: Aċidu alendroniku huwa bisfosfonat li ilu jintuża għall-osteoporożi sa min-nofs id-disgħinijiet.
English: Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol) EMA/793424/2013 rev.1
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu ftehim u l-aġenzija regolatorja tal-mediċini Ġermaniża rreferiet il-kwistjoni lis-CHMP għall-arbitraġġ fit-28 ta' Frar.
English: Suspension (stem cells): 1 ml
Maltese: Sospensjoni (ċelloli staminali): 1 ml
English: EU (MA) number
Maltese: Numru tal-UE (MA)
English: Horses Intraarticular use Vial (plastic)
Maltese: Kunjett (plastik)
English: Suspension for injection
Maltese: Sospensjoni għall-injezzjoni
English: Route of administration
Maltese: Amministrazzjon i
English: Zero days
Maltese: Żwiemel
English: 1 vial of stem cell suspension
Maltese: Kunjett wieħed ta' sospensjoni ta' ċelloli staminali
English: Invented name
Maltese: Żero jiem
English: 483 mg/g Granules
Maltese: 483 mg/g Granijiet
English: EU (MA) Number
Maltese: Numru ta'l-EU (Numru tal-MA)
English: Immediate Packaging
Maltese: Kontenut Daqs talpakkett
English: 1 bottle + 1 dosing spoon
Maltese: 1 flixkun +1 mgħarfa taddożaġġ
English: Oral use bottle (HDPE)
Maltese: Użu Orali flixkun (HDPE) 174g
English: It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg and 10/320/25 mg.
Maltese: Jiġi f'pilloli li jkun fihom l-amlodipina, il-valsartan u l-idroklorotijażide fl-ammonti li ġejjin: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg u 10/320/25 mg.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imprida HCT to Novartis Europharm Limited on 15 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Imprida HCT lil Novartis Europharm Limited fi 15 ta' Ottubru 2009.
English: Hydrochlorothiazide is a diuretic.
Maltese: L-idroklorotijażide huwa dijuretiku.
English: Imprida HCT amlodipine, valsartan and hydrochlorothiazide EPAR summary for the public
Maltese: Imprida HCT amlodipina, valsantran u idroklorotijażide
English: The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Imprida HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Maltese: It-tnaqqis medju fil-pressjoni tad-demm kien madwar 39.7/24.7 mmHg f'pazjenti li kienu fuq Imprida HCT meta mqabbel ma' 32/19.7 mmHg, 33.5/21.5 mmHg u 31.5/19.5 mmHg f'pazjenti li kienu qegħdin jieħdu valsartan/idroklorotijażide, valsartan/amlodipina u idroklorotijażide/amlodipina rispettivament.
English: The most common side effects with Imprida HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Maltese: L-iktar effetti sekondarji komuni b'Imprida HCT (dehru f'madwar pazjent 1 u 10 pazjenti f'100) huma ipokaljemija (livelli baxxi ta' potassju fid-demm), sturdament, uġigħ ta' ras, ipotensjoni (pressjoni taddemm baxxa), dispepsija (qrusa tal-istonku), pollakjurija (frekwenza anormali tal-awrina), għejja u edema (żamma tal-fluwidi).
English: Imprida HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Maltese: Imprida HCT huwa mediċina li fiha t-tliet sustanzi attivi, amlodipina, valsartan u idroklorotijażide.
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Imprida HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Maltese: Barra minn hekk, sar studju ewlieni f'2,271 pazjent b'ipertensjoni minn moderata għal gravi bl-iktar forma qawwija ta' Imprida HCT (320 mg valsartan, 10 mg amlodipina u 25 mg idroklorotijażide).
English: The daily dose of Imprida HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Maltese: Id-doża ta' kuljum ta' Imprida HCT ma għandhiex taqbeż l-10 mg ta' amlodipina, 320 mg ta' valsartan u 25 mg ta' idroklorotijażide.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: II hija vażokostrittur qawwi (sustanza li ddejjaq larterji u l-vini - vasoconstrictor).
English: What is Imprida HCT?
Maltese: X'inhu Imprida HCT?
English: Other information about Imprida HCT:
Maltese: Aktar tagħrif dwar Imprida HCT:
English: What is the risk associated with Imprida HCT?
Maltese: X'inhu r-riskju assoċjat ma' Imprida HCT?
English: Finally, Imprida HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Maltese: Fl-aħħarnett, Imprida HCT ma jistax jintuża f'pazjenti b'ipokaljemija (livelli baxxi ta' potassju fid-demm), iponatremija (livelli baxxi ta' sodju fid-demm) u iperkalċemija (livelli għoljin tal-kalċju fid-demm) li ma jirrispondux għall-kura u f'pazjenti b'iperuriċemija (livelli għoljin ta' aċtu uriku fid-demm) li tikkawża s-sintomi.
English: For the full list of all side effects reported with Imprida HCT, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Imprida HCT, ara lFuljett ta' Tagħrif.
English: The three active substances in Imprida HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Maltese: It-tliet sustanzi attivi f'Imprida HCT huma mediċini antiipertensivi li qegħdin jintużaw diġà fl-Unjoni Ewropea (UE).
English: Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a body hormone called angiotensin II.
Maltese: Valsartan hu tip ta' 'antagonist tar-riċetturi tal-anġjotensina
English: Imprida HCT should not be used in people who may be hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Imprida HCT.
Maltese: Imprida HCT ma għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għas-sustanzi attivi, għal sulfonamidi oħra, għal derivattivi diidropiridiniċi jew għal kwalunkwe ingredjent f'Imprida HCT.
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Maltese: Hija timblokka l-kanali speċjali preżenti fuq il-wiċċ taċċelluli magħrufa bħala kanali tal-kalċju li minnhom normalment il-joni tal-kalċju jidħlu fiċ-ċelluli.
English: Why has Imprida HCT been approved?
Maltese: Għaliex ġie approvat Imprida HCT?
English: Further information on Hulio 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: After 24 weeks, a 20% improvement in symptoms was seen in 74% of Hulio-treated patients (270 of 363) and 76% of Humira treated patients (271 of 358).
Maltese: Wara 24 ġimgħa, ġie osservat titjib ta' 20 % fis-sintomi ta' 74 % tal-pazjenti kkurati b'Hulio (270 minn 363) u 76 % tal-pazjenti kkurati b'Humira (271 minn 358).
English: Other information about Hulio
Maltese: Informazzjoni oħra dwar Hulio
English: Hulio contains the active substance adalimumab and is a ‘biosimilar medicine'.
Maltese: Hulio fih is-sustanza attiva adalimumab u huwa “mediċina bijosimili”.
English: The reference medicine for Hulio is Humira.
Maltese: Ilmediċina ta' referenza għal Hulio hija Humira.
English: What are the risks associated with Hulio?
Maltese: X'inhuma r-riskji assoċjati ma' Hulio?
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Maltese: Effetti sekondarji serji rari oħra (li jistgħu jaffettwaw sa persuna 1 minn kull 1,000) jinkludu nuqqas tal-mudullun milli jipproduċi ċelloli tad-demm, disturb tan-nervituri, lupus u kundizzjonijiet simili għallupus (meta s-sistema immunitarja tattakka t-tessuti tal-pazjent stess, b'hekk tikkawża infjammazzjoni u ħsara fl-organi), u s-sindromu ta' Stevens-Johnson (reazzjoni li tista' twassal għall-mewt, b'sintomi li jixbħu lil dawk tal-influwenza u raxx b'uġigħ li jaffettwa l-ġilda, il-ħalq, l-għajnejn u l-ġenitali).
English: Laboratory studies comparing Hulio with the reference medicine Humira have shown that the active substance in Hulio is highly similar to that in Humira in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Hulio mal-mediċina ta' referenza Humira wrew li s-sustanza attiva f'Hulio hija simili ħafna għal dik f'Humira f'termini ta' struttura, purità u attività bijoloġika.
English: In addition, Hulio was as effective as Humira in a study involving 730 patients with rheumatoid arthritis that was not adequately controlled with the medicine methotrexate.
Maltese: Barra minn hekk, Hulio kien effettiv daqs Humira fi studju li involva 730 pazjent b'artrite rewmatojde li ma kinitx ikkontrollata b'mod adegwat bil-mediċina methotrexate.
English: The active substance in Hulio, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Maltese: Is-sustanza attiva f'Hulio, l-adalimumab, hija antikorp monoklonali (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' sustanza fil-ġisem imsejħa fattur ta' nekrożi tumorali (TNF).
English: As for all medicines, data on the use of Hulio are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Hulio hija ssorveljata kontinwament.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Maltese: L-effetti sekondarji l-aktar komuni b'adalimumab (li dehru f'aktar minn pazjent 1 minn kull 10) huma infezzjonijiet (inkluż dawk fl-imnieħer, fil-griżmejn u fis-sinus), reazzjonijiet fis-sit tal-injezzjoni (ħmura, ħakk, fsada, uġigħ jew nefħa), uġigħ ta' ras, uġigħ fil-muskoli u fl-għadam.
English: This means that Hulio is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Hulio huwa simili ħafna għal mediċina bijoloġika oħra (il-‘mediċina ta' referenza') li diġà hija awtorizzata fl-UE.
English: • rheumatoid arthritis (a disease causing inflammation of the joints);
Maltese: • artrite rewmatojde (marda li tikkawża infjammazzjoni tal-ġogi);
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;
Maltese: • idradenite suppurativa (akne inversa), marda tal-ġilda fit-tul li tikkawża boċċi, axxessi (ġbir ta'
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Maltese: • spondiloartrite assjali (infjammazzjoni tas-sinsla tad-dahar li tikkawża uġigħ fid-dahar), inkluża spondilite ankilożanti u meta r-raġġi X ma jurux mard iżda jkun hemm sinjali ċari ta'
English: • Crohn's disease (a disease causing inflammation of the gut);
Maltese: • marda ta' Crohn (marda li tikkawża infjammazzjoni tal-imsaren);
English: How is Hulio used?
Maltese: Hulio.
English: For the full list of side effects and restrictions with Hulio, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Hulio, ara l-fuljett ta' tagħrif.
English: All these data were considered sufficient to conclude that Hulio will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Hulio jaġixxi bl-istess mod bħal Humira f'termini tal-effettività u tas-sigurtà fl-użu approvat tiegħu.
English: Studies have also shown that giving Hulio produces similar levels of the active substance in the body to giving Humira.
Maltese: L-istudji wrew ukoll li l-għoti ta' Hulio jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Humira.
English: Hulio must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Maltese: Hulio ma għandux jintuża f'pazjenti b'tuberkolożi attiva jew b'infezzjonijiet gravi oħra, jew f'pazjenti b'insuffiċjenza kardijaka moderata sa gravi (il-qalb ma tkunx kapaċi tippompja biżżejjed demm madwar il-ġisem).
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Maltese: • artrite psorjatika (marda li tikkawża rqajja' ħomor, bil-qoxra fuq il-ġilda u infjammazzjoni tal-ġogi);
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
Maltese: • artrite idjopatika ġuvenili poliartikulari u artrite assoċjata ma' entesite attiva (it-tnejn li huma mard rari li jikkawżaw infjammazzjoni tal-ġogi);
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Hulio has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċiediet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Hulio wera li għandu struttura, purità u attività bijoloġika simili ħafna għal Humira u jiġi distribwit bl-istess mod fil-ġisem.
English: • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
Maltese: • uveite mhux infettiva (infjammazzjoni tas-saff ta' taħt l-abjad tal-boċċa tal-għajn).
English: An alert card will also be given to patients.
Maltese: Se tingħata wkoll karta ta' twissija lill-pazjenti.
English: Side effects reported with Hulio are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Hulio huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: An overview of Hulio and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Hulio u għalfejn huwa awtorizzat fl-UE
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Hulio is used to treat.
Maltese: TNF huwa involut flikkawżar tal-infjammazzjoni u jinsab f'livelli għoljin f'pazjenti bil-mard li Hulio jintuża biex jikkura.
English: Because Hulio is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Hulio.
Maltese: Peress li Hulio huwa mediċina bijosimili, l-istudji dwar l-effettività u s-sigurtà tal-adalimumab li saru b'Humira m'għandhomx bżonn jiġu ripetuti kollha għal Hulio.
English: The company that markets Hulio must provide educational packs for doctors who prescribe the medicine.
Maltese: Dawn il-pakketti ser jinkludu informazzjoni dwar is-sigurtà tal-mediċina.
English: In addition, a study in patients with rheumatoid arthritis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Maltese: Barra minn hekk, studju fuq pazjenti bl-artrite rewmatojde wera li l-effetti tal-mediċina huma ekwivalenti għal dawk ta' Humira f'din il-kundizzjoni.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Maltese: Meta teħel mat-TNF, l-adalimumab timblokka l-attività tiegħu, b'hekk tnaqqas l-infjammazzjoni u sintomi oħrajn tal-mard.
English: 2 (Pediatrics Vol. 79 No. 4 April 1987)(2)
Maltese: 2 (Pediatrics Vol. 79 Nru. 4 April 1987)(2)
English: Levothyroxine Alapis contains 200mg/ml of ethanol per dose.
Maltese: Levothyroxine Alapis fih 200 mg/ml ta' ethanol kull doża.
English: There was a significant difference in the occurrence of clinical seizures (P = .021).
Maltese: Kien hemm differenza sinifikanti flokkorrenza ta' aċċessjonijiet kliniċi (P = .021).
English: Nunn et al; Journal of Clinical Pharmacy and Therapeutics (2004) 29, 521-529
Maltese: Evalwazzjoni tal-uniformità mad-doża ta' kampjuni prodotti minn qattara pedjatriċi orali, A.J. Nunn et al; Journal of Clinical Pharmacy and Therapeutics (2004) 29, 521-529
English: The applicant then proposed to use: - a dropper insert for doses between 12.5 µg and 50 µg (5 to 20 drops) and - a 3 mL oral syringe for doses between 50 µg and 200 µg (0.5 to 2 mL) According to the proposed Summary of Product Characteristics (SmPC), the dropper insert will be mainly used for administration to paediatric patients as well as for initial dosing of adults and children over 12 years.
Maltese: Imbagħad l-applikant ippropona li juża: - qattara tal-flixkun għal dożi bejn 12.5 µg u 50 µg (5 sa 20 qatra) u - siringa orali ta' 3 mL għal dożi bejn 50 µg u 200 µg (0.5 sa 2 mL) Skont is-Sommarju tal-Karatteristiċi tal-Prodott propost (SmPC), il-qattara tal-flixkun għandha prinċipalment tintuża għall-għoti lil pazjenti pedjatriċi kif ukoll għad-dożaġġ tal-bidu ta' adulti u ta' tfal 'il fuq minn 12-il sena.
English: Combination of ethanol and propylene glycol
Maltese: Kombinazzjoni ta' ethanol u propylene glycol
English: • The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of l Directive 2001/83/EC.
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-riferiment mibdija mir-Renju Unit skont l-Artikolu 29(4) tadDirettiva 2001/83/KE.
English: The decentralised marketing authorisation application for the medicinal product Levothyroxine is a well-established use application according to Article 10(a) of Directive 2001/83/EC.
Maltese: L-applikazzjoni deċentralizzata għal awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Levothyroxine hija applikazzjoni għall-użu stabbilit sew skont l-Artikolu 10(a) tad-Direttiva 2001/83/KE.
English: Levothyroxine Alapis is an oral drop solution containing levothyroxine sodium as active substance (100 mcg/ml).
Maltese: Is-sustanza attiva levothyroxine, hija sustanza attiva stabbilita deskritta fil-Farmakopea Ewropea. Levothyroxine Alapis huwa soluzzjoni ta' qtar orali li fiha levothyroxine sodium bħala s-sustanza attiva (100 mcg/ml).
English: Two groups of infants were treated with two doses of propylene glycol; 0.3 g/day and 3 g/day in an IV multivitamin solution, during two consecutive 19month periods in a retrospective design.
Maltese: Żewġ gruppi ta' trabi ngħataw kura b'żewġ dożi ta' propylene glycol; 0.3 g/kuljum u 3 g/kuljum f'soluzzjoni ta' multivitamini mgħotija ġol vina, matul żewġ perjodi konsekuttivi ta' 19-il xahar f'disinn retrospettiv.
English: The excipients are glycerol, propylene glycol, ethanol and purified water, which comply with the respective Ph.Eur monographs.
Maltese: L-eċċipjenti huma glycerol, propylene glycol, ethanol u ilma ppurifikat, li huma konformi mal-monografiji rispettivi tal-Ph.Eur.
English: Both ethanol and propylene glycol are initially metabolised by alcohol dehydrogenase.
Maltese: Kemm ethanol kif ukoll propylene glycol jiġu inizjalment metabolizzati minn alcohol dehydrogenase.
English: The study by MacDonald et al2, seems relevant as daily doses of propylene glycol similar to what can be expected from Levothyroxine Alapis were studied in one of the study arms.
Maltese: L-istudju minn MacDonald et al2, jidher rilevanti peress li f'waħda mill-fergħat tal-istudju ġew studjati dożi ta' kuljum ta' propylene glycol simili għal dak li jista' jiġi mistenni minn Levothyroxine Alapis.
English: The guidance “Guideline on the excipients in the label and the package leaflet of medicinal products for human use” states that if the content of ethanol is 100 mg - 3g per dose, the following should be stated in the PL: ‘This medicinal product contains < > vol % ethanol (alcohol), i.e. up to < > mg per dose, equivalent to < > ml beer, < > ml wine per dose.
Maltese: Il-gwida “Linja Gwida dwar l-eċċipjenti fittabella u fil-fuljett ta' tagħrif ta' prodotti mediċinali għall-użu mill-bniedem” tgħid li jekk il-kontenut ta' ethanol jkun ta' 100 mg - 3g kull doża, dan li ġej għandu jiġi ddikjarat fil-PL: ‘Dan il-prodott mediċinali fih < > vol % ta' ethanol (alkoħol), jiġifieri sa < > mg kull doża, ekwivalenti għal < > ml ta' birra, < > ml ta' nbid kull doża.
English: • The Committee reviewed all the data that was available to address the potential serious risk to public health, in particular with regard to the safety of Levothyroxine Alapis 100 microgram/ml oral drops solution.
Maltese: • Il-Kumitat irreveda d-dejta kollha disponibbli biex jindirizza r-riskju serju potenzjali għas-saħħa pubblika, b'mod partikolari fir-rigward tas-sigurtà ta' Levothyroxine Alapis 100 mikrogramma/ml soluzzjoni ta' qtar orali.
English: The possible medication errors caused by the dropper insert were discussed by the CHMP:
Maltese: L-iżbalji possibbli fl-għoti tal-mediċina kkawżati mill-qattara tal-flixkun ġew diskussi mis-CHMP:
English: Safety of excipients (ethanol / propylene glycol) in paediatric population The excipients used in Levothyroxine Alapis are ethanol, propylene glycol, glycerol and water and comply with the Ph. Eur monographs.
Maltese: L-eċċipjenti użati fi Levothyroxine Alapis huma ethanol, propylene glycol, glycerol u ilma u huma konformi mal-monografiji tal-Ph.
English: The proposed indications for Levothyroxine Alapis are for: the treatment of hypothyroidism (congenital or acquired, including diffuse non-toxic goiter), hypothyroidism forms of Hashimoto's thyroiditis and thyroid carcinoma.
Maltese: L-indikazzjonijiet proposti għal Levothyroxine Alapis huma: għall-kura tal-ipotirojdiżmu (konġenitali jew miksub, inkluż goiter diffuż mhux tossiku), għall-forom tal-ipotirojdiżmu tat-tirodijte ta' Hashimoto u għall-karċinoma tat-tirojde.
English: Levothyroxine Alapis is a solution with low viscosity, which gives a fast drop rate.
Maltese: Levothyroxine Alapis huwa soluzzjoni b'viskożità baxxa, li tagħti rata mgħaġġla ta' qtar.