FrancophonIA/ELRC3.0 huggingface dataset:
English: - The tablets are supplied in Aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 84, 90,
Maltese: - Il-pilloli huma disponibbli f'folji tal-Aluminju/aluminju f'pakketti ta' 14, 28, 30, 50, 56, 84, 90,
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Maltese: Tibdiliet simili dehru fi provi kkontrollati komparattivi b'pioglitazone f'pazjenti kkurati b'metformin (tnaqqis relattiv fl-emoglobina 3 - 4% u fl-ematokrita 3.6 - 4.1%) u fi kwantità inqas b'sulphonylurea u bl-insulina
English: - The tablets are supplied in Aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets or 50 x 1 tablets in Aluminium/aluminium perforated unit dose blisters.
Maltese: Folji tal-Aluminju/aluminju, pakketti ta' 14, 28, 30, 50, 56, 84, 90, 98, 112 u 196 pillola. 50 x 1 pillola f'folji perforati ta' doża waħda tal-Aluminju/aluminju.
English: Musculoskeletal and connective tissue disorders fracture bone4
Maltese: Disturbi muskoluskeletriċi u tattessut konnettiv ksur ta' għadam4
English: Pioglitazone Teva Pharma 30 mg tablets
Maltese: Pioglitazone Teva Pharma 30 mg pilloli
English: Metabolism and nutrition disorders hypo-glycaemia uncommon very common common appetite increased uncommon
Maltese: Disturbi fil-metabolizmu u n-nutrizzjoni ipoglicemija mhux komuni ħafna żieda fl-aptit mhux
English: 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 112 tablets 196 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 50 pillola
English: Pioglitazone is contraindicated in patients with: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
Maltese: - sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi elenkati f'sezzjoni 6.1. - insuffiċjenza kardijaka jew passat ta' insuffiċjenza kardijaka (NYHA stadju I sa IV).
English: Pioglitazone Teva Pharma 45 mg tablets
Maltese: Pioglitazone Teva Pharma 45 mg pilloli
English: In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year.
Maltese: Fi studju ta' sentejn b'terapija kombinata li qabbel pioglitazone ma' gliclazide meta miżjuda ma' metformin, il-kontroll gliċemiku mkejjel bħala it-tibdil medju mill-linja bażika ta' HbA1c kien simili bejn il-gruppi ta' kura wara l ewwel sena.
English: ‘15' on one side and ‘TEVA' on the other side.
Maltese: ‘15' fuq naħa waħda u ‘TEVA' fuq in-naħa l-oħra.
English: Pioglitazone Teva Pharma 15 mg tablets
Maltese: Pioglitazone Teva Pharma 15 mg pilloli
English: Pioglitazone Teva Pharma contains pioglitazone.
Maltese: Pioglitazone Teva Pharma fih is-sustanza attiva pioglitazone.
English: Pregnancy
Maltese: Investigazzjoniji
English: These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Maltese: Dawn is-sejbiet kienu osservati fi speċi differenti b'konċentrazzjonijiet fil-plażma ≤ 4 darbiet lespożizzjoni klinika.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu
English: It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately.
Maltese: Huma mediċina antidijabetika użata biex tikkura dijabete mellitus tat-tip 2 (mhux dipendenti mill-insulina) fl-adulti, meta metformin ma jkunx adattat jew ikun naqas li jaħdem b'mod adegwat.
English: Pioglitazone Teva Pharma 15 mg tablets EU/1/12/758/001-010
Maltese: FIS-SUQ EU/1/12/758/001-010
English: In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those >65 years compared to 4.0% in patients less than 65 years.
Maltese: F'pazjenti fuq l-insulina mingħajr pioglitazone, l-inċidenża ta' insuffiċjenza tal-qalb kienet 8.2% f'dawk ≥ 65 sena meta mqabbel ma' 4.0% f'pazjenti li għandhom inqas minn 65 sena.
English: What Pioglitazone Teva Pharma looks like and contents of the pack - Pioglitazone Teva Pharma 15 mg tablets are white to off white, round, convex with the number
Maltese: Id-Dehra ta' Pioglitazone Teva Pharma u d-daqs tal-pakkett - Pioglitazone Teva Pharma 15 mg huma pilloli bojod għal ofwajt, tondi, mżaqqin bin-numru
English: When Pioglitazone Teva Pharma is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Maltese: Meta Pioglitazone Teva Pharma jittieħed flimkien ma' mediċini oħra wżati għall-kura tad-dijabete (bħal insulina, chlorpropamide, glibenclamide, gliclazide, tolbutamide), it-tabib tiegħek jgħidlek jekk għandekx bżonn tieħu doża inqas tal-mediċini tiegħek.
English: Ireland
Maltese: България
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/758/021-030
Maltese: FIS-SUQ EU/1/12/758/021-030
English: What Pioglitazone Teva Pharma contains - The active substance is pioglitazone.
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Pioglitazone Teva Pharma - Is-sustanza attiva hija pioglitazone.
English: Teл.
Maltese: T TL
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/758/011-020
Maltese: FIS-SUQ EU/1/12/758/011-020
English: - Pioglitazone Teva Pharma 30 mg tablets are white to off white, round, convex with the number ‘30' on one side and ‘TEVA' on the other side.
Maltese: - Pioglitazone Teva Pharma 30 mg huma pilloli bojod għal ofwajt, tondi, mżaqqin bin-numru ‘30' fuq naħa waħda u ‘TEVA' fuq in-naħa l-oħra.
English: How to store Pioglitazone Teva Pharma
Maltese: Jekk tinsa tieħu Pioglitazone Teva Pharma
English: Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Maltese: Pioglitazone huwa indikat ukoll għall-użu flimkien ma' insulina f'pazjenti adulti b'dijabete mellitus tat-tip 2 b'kontroll gliċemiku insuffiċjenti bl-insulina u li għalihom metformin mhux adattat minħabba kontraindikazzjonijiet jew intolleranza (ara sezzjoni 4.4).
English: Each Pioglitazone Teva Pharma 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola Pioglitazone Teva Pharma 45 mg fiha 45 mg ta' pioglitazone (bħala hydrochloride).
English: In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged >65 years compared with those less than 65 years (9.7% compared to 4.0%).
Maltese: F'dan l-istudju f'pazjenti li qed jirċievu pioglitazone u l-insulina, kien osservat perċentwal ogħla ta' pazjenti b'insuffiċjenza tal-qalb f'pazjenti li għandhom ≥ 65 sena meta mqabbla ma'dawk iżgħar minn 65 sena (9.7% meta mqabbla ma' 4.0%).
English: INFORMATION IN BRAILLE Pioglitazone Teva Pharma 15 mg tablets
Maltese: Informazzjoni għall-utent Pilloli Pioglitazone Teva Pharma 15 mg
English: Luxembourg/Luxemburg ratiopharm GmbH Tél/Tel: +49 731 402 02
Maltese: Luxembourg/Luxemburg ratiopharm GmbH
English: Pioglitazone Teva Pharma 30 mg tablets Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola Pioglitazone Teva Pharma 30 mg fiha 30 mg ta' pioglitazone (bħala hydrochloride).
English: common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Maltese: komuni (jista' jaffettwa sa persuna waħda minn fost 10) - infezzjoni respiratorja - vista mhux normali - żieda fil-piż - tmewwit mhux komuni (jista' jaffettwa sa persuna waħda minn fost 100)
English: common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon alanine aminotransferase increased7
Maltese: - zokkor fl-awrina, proteina fl-awrina - żieda fl-enżimi - vertiġini - tgħoroq - għeja
English: Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 3 820 73 73
Maltese: Teva Pharma Belgium N.V./S.A./AG
English: Each Pioglitazone Teva Pharma 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola Pioglitazone Teva Pharma 15 mg fiha 15 mg ta' pioglitazone (bħala hydrochloride).
English: Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjoni fil-passaġġ respiratorju ta' fuq bronkite sinusite mhux mhux mhux mhux mhux
English: - Pioglitazone Teva Pharma 45 mg tablets are white to off white, round, convex with the number ‘45' on one side and ‘TEVA' on the other side.
Maltese: - Pioglitazone Teva Pharma 45 mg huma pilloli bojod għal ofwajt, tondi, mżaqqin bin-numru ‘45'
English: Pioglitazone Teva Pharma 45 mg tablets Each tablet contains 45 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 45 mg ta' pioglitazone (bħala hydrochloride).
English: Pioglitazone Teva Pharma 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Maltese: Pioglitazone Teva Pharma 15 mg pilloli Kull pillola fiha 15 mg ta' pioglitazone (bħala hydrochloride).
English: How to take Pioglitazone Teva Pharma
Maltese: Mediċini oħra u Pioglitazone Teva Pharma
English: Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin dizziness common insomnia uncommon uncommon uncommon uncommon uncommon
Maltese: F'kull klassi tas-sistemi u tal-organi, l-effetti mhux mixtieqa huma mniżżla skont il-frekwenza, bl-aktar frekwenti l-ewwel, segwit minn kemm huma serji, bl-aktar serji mniżżla l-ewwel.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu309708.
Maltese: ema.europa.eu/medicines/human/orphan-designations/eu309708.
English: Further information on Palynziq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Palynziq.
Maltese: ema.europa.eu/medicines/human/EPAR/Palynziq.
English: Palynziq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 January 2010.
Maltese: Palynziq ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-28 ta' Jannar 2010.
English: Palynziq contains the active substance pegvaliase.
Maltese: Palynziq fih is-sustanza attiva pegvalise.
English: Palynziq is available as pre-filled syringes (2.5, 10 and 20 mg) for injection under the skin.
Maltese: Palynziq jiġi bħala siringi mimlija minn qabel (2.5, 10 u 20 mg) għall-injezzjoni taħt il-ġilda.
English: Palynziq is a medicine that is used to treat phenylketonuria (PKU) in adults and adolescents from 16 years of age.
Maltese: Palynziq huwa mediċina użata fil-kura tal-fenilketonurja (PKU) fl-adulti u l-adoloxxenti minn 16-il sena ‘l fuq.
English: The active substance in Palynziq, pegvaliase, is a bacterial enzyme that can break down phenylalanine, thereby stopping phenylalanine from building up in the body and helping to relieve the symptoms of phenylketonuria.
Maltese: Is-sustanza attiva f'Palynziq, il-pegvaliase, hija enzima batterika li tista' tkisser il-fenilalanina, u b'hekk twaqqaf il-fenilalanina milli tiżdied fil-ġisem u tgħin biex ittaffi s-sintomi tal-fenilketonurja.
English: The most significant allergic reactions include acute systemic allergic reaction, angioedema (swelling under the skin in areas such as the face, throat, arms and legs), and serum sickness (allergic reaction caused by animal proteins or serum).
Maltese: Ir-reazzjonijiet l-aktar allerġiċi sinifikanti jinkludu reazzjoni allerġika sistemika akuta, anġjoedema (nefħa taħt il-ġilda f'żoni bħall-wiċċ, il-gerżuma, id-dirgħajn u r-riġlejn), u l-mard tas-serum (reazzjoni allerġika kkawżata millproteini jew mis-serum tal-annimali).
English: Other information about Palynziq
Maltese: Informazzjoni oħra dwar Palynziq
English: The enzyme in pegvaliase is ‘pegylated' (attached to a chemical called PEG), allowing it to remain in the body and to act for longer.
Maltese: L-enzima f'pegivaliase hija “pegilata” (mehmuża ma' sustanza kimika msejħa PEG), li tippermettilha tibqa' filġisem u taġixxi għal aktar fit-tul.
English: As for all medicines, data on the use of Palynziq are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Palynziq hija ssorveljata kontinwament.
English: For the full list of side effects of Palynziq, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Palynziq, ara l-fuljett ta' tagħrif.
English: After 8 weeks of treatment, blood phenylalanine levels remained under control in patients taking Palynziq but they returned to pre-treatment levels in patients on placebo, showing that Palynziq was more effective than placebo in reducing blood phenylalanine levels and keeping them within an acceptable range.
Maltese: Wara 8 ġimgħa ta' kura, il-livelli ta' fenilalanina fid-demm baqgħu taħt kontroll f'pazjenti li kienu qed jieħdu Palynziq iżda reġgħu lura għal-livelli ta' qabel bdiet il-kura f'pazjenti li ngħataw plaċebo, li juri li Palynziq kien aktar effettiv mill-plaċebo fit-tnaqqis tal-livelli ta' fenilalanina fid-demm u fiż-żamma tagħhom fi skala aċċettabbli.
English: Eighty-six patients who responded to treatment (i.e. whose blood phenylalanine levels were reduced by at least 20%) where then either kept on the same dose of Palynziq or were given placebo (a dummy treatment).
Maltese: Sitta u tmenin pazjent li rrispondew għall-kura (jiġifieri li l-livelli ta' fenilalanina fid-demm tnaqqsu b'mill-inqas 20%) jew żammew l-istess doża ta' Palynziq jew ingħataw plaċebo (kura finta).
English: What are the risks associated with Palynziq?
Maltese: X'inhuma r-riskji assoċjati ma' Palynziq?
English: Patients with this genetic disease cannot process the amino acid phenylalanine from dietary protein, and as a result the amino acid builds up in the blood to abnormally high levels, causing problems in the nervous system.
Maltese: Il-pazjenti li jbatu minn din il-marda ġenetika ma jistgħux jipproċessaw l-amino aċidu fenilalanina millproteina tad-dieta, u minħabba f'hekk l-aminoaċidu jinbena fid-demm f'livelli għolja b'mod anormali, u jikkawża problemi fis-sistema nervuża.
English: The safety of Palynziq is considered acceptable, and important side effects such as allergic reactions are considered manageable with additional stringent measures (see below).
Maltese: Is-sigurtà ta' Palynziq hija kkunsidrata aċċettabbli, u effetti sekondarji importanti bħal reazzjonijiet allerġiċi huma kkunsidrati maniġġabbli b'miżuri stretti addizzjonali (ara hawn taħt).
English: The most common side effects with Palynziq (which may affect more than 7 in 10 people) are reactions at the injection site, pain in the joints and allergic reactions.
Maltese: L-effetti sekondarji l-aktar komuni b'Palynziq (li jistgħu jaffettwaw aktar minn 7 persuni minn kull 10 ) huma reazzjonijiet fis-sit tal-injezzjoni, uġigħ fil-ġogi u reazzjonijiet allerġiċi.
English: It was shown that for the majority of patients continued treatment with Palynziq for 18 months was effective at keeping blood phenylalanine levels under control (below 600 micromoles per litre).
Maltese: Intwera li għall-maġġoranza tal-pazjenti li komplew bil-kura ta' Palynziq għal 18-il xahar , il-kura kienet effettiva biex il-livelli ta' fenilalanina fid-demm jinżammu taħt kontroll (taħt 600 mikromoli għal kull litru).
English: Palynziq must not be used in patients who have had an allergic reaction to pegvaliase, to any of the other components of Palynziq or to any other pegylated medicine.
Maltese: Palynziq ma għandux jintuża f'pazjenti li kellhom reazzjoni allerġika għall-pegvaliase, għal kwalunkwe wieħed mill-komponenti l-oħra ta' Palynziq jew għal kwalunkwe mediċina pegilata oħra.
English: The dose and frequency of injection are then increased gradually (up to a maximum dose of 60 mg once a day) to achieve adequate control of phenylalanine blood levels.
Maltese: Imbagħad, id-doża u l-frekwenza tal-injezzjoni jiżdiedu gradwalment (sa doża massima ta' 60 mg darba kuljum) biex jinkiseb kontroll adegwat tal-livelli ta' fenilalanina fid-demm.
English: Why is Palynziq authorised in the EU?
Maltese: Għaliex Palynziq huwa awtorizzat fl-UE?
English: An overview of Palynziq and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Palynziq u għalfejn huwa awtorizzat fl-UE
English: The main study investigating Palynziq in patients with PKU consisted of different parts.
Maltese: Aktar informazzjoni dwar Palynziq tinstab fis-sit elettroniku tal-Aġenzija:
English: Palynziq was shown to be effective at reducing levels of blood phenylalanine and keeping them under control.
Maltese: Palynziq intwera li huwa effettiv biex inaqqas il-livelli ta' fenilalanina fid-demm u jżommhom taħt kontroll.
English: How is Palynziq used?
Maltese: Palynziq?
English: During the first part, all patients were given Palynziq at a dose of 20 or 40 mg for up to 13 weeks.
Maltese: Matul l-ewwel parti, il-pazjenti kollha ngħataw Palynziq f'doża ta' 20 jew 40 mg għal massimu ta' 13-il ġimgħa.
English: Throughout the study, patients were required to maintain a constant level of dietary protein intake, to ensure that changes in blood phenylalanine levels could be attributed to treatment rather than to changes in protein intake.
Maltese: Matul listudju kollu, il-pazjenti kienu meħtieġa jżommu livell kostanti ta' teħid ta' proteini fid-dieta, biex jiżguraw li l-bidliet fil-livelli ta' fenilalanina fid-demm jistgħu jiġu attribwiti għall-kura aktar milli għal bidliet fit-teħid tal-proteini.
English: In the extension phase of the study patients received an individual optimized dose of Palynziq.
Maltese: Fil-fażi tal-estensjoni tal-istudju, il-pazjenti ngħataw doża ottimizzata individwali ta' Palynziq.
English: Anise oil EMA/412178/2016
Maltese: EMA/412178/2016
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/412178/2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: They must also not be used in patients who are allergic to aniseed or to plants of the Apiaceae family (Umbelliferae) (caraway, celery, coriander, dill, fennel) or anethole.
Maltese: Dawn m'għandhomx jintużaw f'pazjenti li huma allerġiċi għall-aniżetta jew għal pjanti tal-familja Apiaceae (Umbelliferae) (karwija, karfus, kosbor, xibt, bużbież) jew anethole.
English: What is anise oil?
Maltese: X'inhu ż-żejt tal-anisi?
English: How are anise oil medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini li fihom iż-żejt tal-anisi?
English: Further information on the HMPC assessment of anise oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini li fihom iż-żejt tal-anisi, inklużi d-dettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' (‘All Documents') fil-websajt talAġenzija:
English: Anise oil is the common name for the essential oil obtained from the dry ripe fruits of the plant Pimpinella anisum L.
Maltese: Żejt tal-anisi huwa l-isem komuni għaż-żejt essenzjali miksub mill-frott misjur niexef tal-pjanta Pimpinella anisum L.
English: The HMPC conclusions on the use of these anise oil medicines for indigestion complaints and coughs are based on their ‘traditional use' .
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' dawn il-mediċini li fihom iż-żejt tal-anisi għal ilmenti ta' indiġestjoni ħafifa u sogħla huma bbażati fuq l-‘użi tradizzjonali' tagħhom.
English: What are the risks associated with anise oil medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom iż-żejt tal-anisi?
English: Further information on the risks associated with these anise oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom iż-żejt tal-anisi, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (‘All Documents') fil-websajt tal-Aġenzija:
English: In its assessment, the HMPC considered studies in laboratory tests which showed anise oil to have a relaxing effect on the muscle of the gut and airways.
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra għadd ta' studji kliniċi minn testijiet tal-laboratorju li wrew li ż-żejt tal-anisi għandu effett rilassanti fuq il-muskolu tal-imsaren u tal-passaġġi tal-arja.
English: Other information about anise oil medicines
Maltese: Aktar informazzjoni dwar il-mediċini li fihom iż-żejt tal-anisi
English: Any applications for the licensing of medicines containing anise oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom iż-żejt tal-anisi għandha titressaq lillawtoritajiet nazzjonali responsabbli għall-prodotti mediċinali, li ser jivvalutaw l-applikazzjoni għallmediċina tal-ħxejjex u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: Aniseed oil medicines must not be used in children and adolescents under 18 years.
Maltese: Il-mediċini li fihom iż-żejt tal-anisi ma għandhomx jintużaw fl-adulti u fl-adolexxenti taħt it-18-il sena.
English: The HMPC conclusions only cover anise oil preparations which are obtained by steam distillation of the dry ripe fruits.
Maltese: Ir-riproduzzjoni hija awtorizzata kemm-il darba jissemma' s-sors oriġinali.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of anise oil.
Maltese: Dan huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għall-Prodotti tal-Ħxejjex Mediċinali (HMPC) dwar l-użu mediċinali taż-żejt tal-anisi.
English: An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06; 35 trials and 6,769 patients) was observed in patients treated with recombinant human erythropoietin.
Maltese: Żieda fir-riskju relattiv ta' episodji tromboembolitiċi (RR 1.67, 95 % CI: 1.35, 2.06, 35 studji u 6,769 pazjent) kienet osservata f'pazjenti kkurati b'eritropojetin rikombinanti uman.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8,167 patients).
Maltese: Meta-analiżi tat-tagħrif tas-sopravivenza globali pproduċiet hazard ratio point estimate ta' 1.08 favur il-kontrolli (95 % CI: 0.99, 1.18; 42 studji u 8,167 pazjent).
English: Epoetin theta is a protein produced by biotechnology.
Maltese: Epoetin theta huwa proteina magħmula b'teknoloġija.
English: LIST OF EXCIPIENTS
Maltese: LISTA EĊĊIPJENTI
English: The safety and efficacy of Eporatio in children and adolescents aged up to 17 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Eporatio fit-tfal u l-adolexxenti sa età ta' 17-il sena ma ġewx stabbiliti.
English: How to store Eporatio
Maltese: TUŻAX Eporatio
English: It should be allowed to reach a comfortable temperature (15 °C - 25 °C) for injection.
Maltese: Għandha titħalla tilħaq temperatura komda (15°C-25°C) għall-injezzjoni.