FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical studies have shown that there are no clinically significant interactions between lamivudine and zidovudine.
Maltese: Studji kliniċi urew li m'hemm l-ebda interazzjonijiet klinikament sinifikanti bejn lamivudine u zidovudine.
English: Pharmacotherapeutic group: Antivirals for treatment of HIV infections, combinations, ATC Code: J05AR01
Maltese: Antivirali għal kura ta' infezzjonijiet b'HIV, kombinazzjonijiet, Kodiċi
English: If Combivir is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of both liver function tests and markers of HBV replication for 4 months is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.
Maltese: Jekk Combivir jitwaqqaf f'pazjenti ko-infettati bil-virus ta' l-epatite B, huwa rrakkomandat monitoraġġ perijodiku ta' testijiet għal 4 xhur għall-funzjoni tal-fwied u sustanzi li juru r-replikazzjoni ta' l-HBV,
English: • breakdown of muscle tissue
Maltese: Disturbi muskulo-skeletali u tal-connective tissue
English: VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com
Maltese: Laboratorios ViiV Healthcare, S.L. Tel: + 34 902 051 260 es-ci@viivhealthcare.com
English: White to off-white, capsule-shaped film-coated scored tablets engraved with “GXFC3” on both sides.
Maltese: Pilloli miksijin b'rita, f'forma ta' kapsula ta' lewn abjad jagħti fl-offwajt u b'GXFC3 inċiż fuq iż-żewġ naħat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER PACK OUTER CARTON
Maltese: Aplasija ta' ċelluli ħomor puri
English: Each pack type contains 60 film-coated tablets.
Maltese: Kull pakkett jkun fih 60 pillola miksija b'rita.
English: How to store Combivir
Maltese: X'fih Combivir
English: NAME OF THE MEDICINAL PRODUCT Combivir 150 mg/300 mg tablets Lamivudine/zidovudine
Maltese: Informazzjoni għall-utent Combivir 150 mg/300 mg pilloli miksijin b'rita lamivudine/zidovudine
English: Lamivudine has not shown any genotoxic activity in in vivo studies at doses that gave plasma concentrations up to 40-50 times higher than clinical plasma levels.
Maltese: Lamivudine ma kienx ġenotossiku in vivo f'dożi li rriżultaw f'konċentrazzjonijiet fil-plażma ta' madwar 40-50 darba aktar mil-livelli kliniċi fil-plażma.
English: Subjects receiving lamivudine and zidovudine with or without additional concomitant antiretroviral therapies and who already present with the M184V mutant virus also experience a delay in the onset of mutations that confer resistance to zidovudine and stavudine (Thymidine Analogue Mutations; TAMs).
Maltese: Pazjenti li jkunu ħadu lamivudine u zidovudine, weħedhom jew flimkien ma' terapiji antiretrovirali addizzjonali fl-istess ħin, u li diġa' jkollhom virus mutant M184 idumu aktar biex ikollhom mutazzjonijiet li jikkonferixxu reżistenza għal zidovudine u għal stavudine (Mutazzjonijiet Analogi ta'
English: Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of zidovudine (see section 4.4).
Maltese: Każijiet ta' aċidożi lattika, kultant fatali, li normalment ikunu assoċjati ma' epatomegalija severa u steatożi tal-fwied, ġew rappurtati bl-użu ta' zidovudine (ara taqsima 4.4).
English: ANTICONVULSANTS Phenobarbital/Lamivudine
Maltese: Phenobarbital/Lamivudine
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
Maltese: Ġieli kien hawn każi ta' funzjoni mitokondrjali ħażina fi trabi HIV-negative esposti għal analogi nukleosidiin utero u/jew wara t-twelid: dawn kienu b'mod predomaninati jikkonċernaw kura b'korsijiet li fihom zidovudine.
English: 3'-amino-3'deoxythymidine (AMT) has been identified as a metabolite of zidovudine following intravenous dosing.
Maltese: 3'-amino-3'-deoxythymidine
English: Children weighing between 21 kg and 30 kg: the recommended oral dose of Combivir is one-half tablet taken in the morning and one whole tablet taken in the evening.
Maltese: Tfal li jiżnu bejn il-21kg u t-30kg: id-doża orali ta' Combivir irrakomandata hija ta' nofs pillola filgħodu u pillola sħiħa filgħaxija.
English: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Maltese: Ikkunsidra monitoraġġ aktar frekwenti tat-tagħbija virali talHIV-1 meta l-għoti flimkien kroniku ma jkunx jista' jiġi evitat.
English: Uncommon: Neutropenia and anaemia (both occasionally severe), thrombocytopenia Very rare: Pure red cell aplasia
Maltese: Mhux komuni: Newtropenja u anemija (it-tnejn li huma kultant serji), tromboċitopenja
English: Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection (see section 4.2).
Maltese: Combivir huwa indikat għal terapija antiretrovirali kombinata għall-kura ta' adulti u adolexxenti ta' 'l fuq minn 12-il sena kontra l-Virus ta' l-Immunodefiċjenza fil-Bniedem (HIV) (ara sezzjoni 4.2).
English: • lactic acidosis (excess lactic acid in the blood; see the next section, ‘Other possible side effects of combination therapy for HIV')
Maltese: • aċidożi lattika (aċidu lattiku żejjed fid-demm, ara s-sezzjoni li jmiss, “Effetti sekondarji oħra li jista' jkun hemm b'terapija b'taħlita ta' mediċini għall-HIV”)
English: Adverse reactions have been reported during therapy for HIV disease with lamivudine and zidovudine separately or in combination.
Maltese: Ġew rappurtati reazzjonijiet avversi waqt terapija għall-marda tal-HIV b'lamivudine u b'zidovudine separatament jew flimkien.
English: Musculoskeletal and connective tissue disorders Common : Myalgia
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue
English: • numbness
Maltese: Sentejn
English: Rare : Cough
Maltese: Rari Ħafna:
English: The extent of lamivudine and zidovudine absorption (AUC∞) and estimates of half-life following administration of Combivir with food were similar when compared to fasting subjects, although the rates of absorption (Cmax, tmax) were slowed.
Maltese: L-ammont ta' assorbiment ta' lamivudine u ta' zidovudine (AUC∞) u stimi talhalf-life wara t-teħid ta' Combivir ma' l-ikel kienu l-istess meta mqabbla ma' pazjenti sajma, għalkemm ir-rati ta' assorbiment (Cmax, tmax) kienu inqas.
English: Their main modes of action are as chain terminators of viral reverse transcription.
Maltese: Il-metodi prinċipali ta' azzjoni tagħhom huma li jwaqqfu l-katina tar reverse transcription tal-virus.
English: Adults and adolescents weighing at least 30 kg: the recommended dose of Combivir is one tablet twice daily.
Maltese: Adulti u adolexxenti li jiżnu mill-anqas 30kg: id-doża rrakkomandata ta' Combivir hi ta' pillola waħda darbtejn kuljum.
English: For situations where discontinuation of therapy with one of the active substances of Combivir, or dose reduction is necessary separate preparations of lamivudine and zidovudine are available in tablets/capsules and oral solution.
Maltese: F'sitwazzjonijiet fejn il-kura b'waħda mis-sustanzi attivi ta' Combivir ma titkompliex, jew ikun hemm bżonn tnaqqis fid-doża, hemm preparazzjonijiet separati ta' lamivudine u zidovudine bħala pilloli/kapsuli u soluzzjoni orali.
English: Dosages of 180 mg/m2 four times daily in children produced similar systemic exposure (24 hour AUC 40.0 h µM or 10.7 h µg/ml) as doses of 200 mg six times daily in adults (40.7 h µM or 10.9 h µg/ml).
Maltese: 7hr μg/ml) daqs dożi ta' 200mg sitt darbiet kuljum f'adulti (40.7 hr μM jew 10.
English: Nervous system disorders Common: Headache, insomnia Very rare: Peripheral neuropathy (or paraesthesiae)
Maltese: Rari ħafna: Anemija aplastika Disturbi fil-metaboliżmu u n-nutrizzjoni
English: Dosage adjustments in patients with haematological adverse reactions: Dosage adjustment of zidovudine may be necessary if the haemoglobin level falls below 9 g/dl or 5.59 mmol/l or the neutrophil count falls below 1.0 x 109/l (see sections 4.3 and 4.4).
Maltese: Tibdil fid-dożaġġ ta' zidovudine jista'' jkun meħtieġ jekk il-livelli ta' emoglobina jitbaxxew għal inqas minn 9 g/dl jew 5.59 mmol/l jew jekk l-għadd tan-newtrofili jitbaxxa għal inqas minn 1.0 x 109/l (ara taqsimiet 4.3 u 4.4).
English: Hepatobiliary disorders
Maltese: ANTIMIKOBATTERIĊI
English: For children who weigh less than 14 kg lamivudine and zidovudine (the ingredients of Combivir) should be taken separately.
Maltese: Għal tfal li jiżnu anqas minn 14-il kg lamivudine u zidovudine (is-sustanzi ta' Combivir) għandhom jittieħdu separatament.
English: In any case, initiation of susceptible NRTI's should always be preferred to maintenance of lamivudine therapy.
Maltese: F'kull ċirkostanza, huwa dejjem preferibbli li jinbdew NRTI suxxettibli għal terapija regolari b'lamivudine.
English: Skin and subcutaneous tissue disorders Common: Rash, alopecia Rare: Angioedema
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni: Raxx, alopeċja Rari:
English: Tablet film coat:
Maltese: Farmakokinetika fit-tqala:
English: • clarithromycin, an antibiotic if you are taking clarithromycin, take your dose at least 2 hours before or after you take your Combivir.
Maltese: • clarithromycin, antibijotiku jekk qed tieħu clarithromycin, hu d-doża tiegħek mill-anqas sagħtejn qabel jew wara li tieħu
English: Combivir was shown to be bioequivalent to lamivudine 150 mg and zidovudine 300 mg given as separate tablets, when administered to fasting subjects.
Maltese: Combivir irriżulta li kien bioekwivalenti għal 150 mg lamivudine u 300 mg zidovudine bħala pilloli separati, meta mogħtija lil pazjenti sajma.
English: Tel: +385 1 6051 999
Maltese: GlaxoSmithKline d.o.o. Tel: + 385 1 6051 999
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Maltese: Pazjenti li kienu diġa' jbatu b'disfunzjoni tal-fwied, inkluża l-epatite kronika attiva, ikollhom żieda fil frekwenza ta' anormalitajiet fil-funzjoni tal-fwied waqt it-terapija kombinata antiretrovirali, u għandhom ikunu mmonitorjati bħas-soltu.
English: You may have problems with your bones
Maltese: Hemm il-possibbiltà li l konċentrazzjonijiet ta'
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti nfettati bl-HIV, b'defiċjenza severa fl-immunita'fiż-żmien li tkun inbdiet it-terapija antiretrovirali kkombinata (TARK), jista' jkun hemm reazzjoni ta' infjammazzjoni għall-mikrobi opportunistiċi asintomatiċi jew residwali.
English: Biotransformation
Maltese: ANTIRETROVIRALI
English: Ware
Maltese: FEJN
English: These occurred more frequently at higher dosages (1200-1500 mg/day) and in patients with advanced HIV disease (especially when there is poor bone marrow reserve prior to treatment), and particularly in patients with CD4 cell counts less than 100/mm3 (see section 4.4).
Maltese: Dawn kienu aktar spissi f'dożaġġi għolja (1200-1500 mg/kuljum) u f'pazjenti bil-marda ta' l-HIV avanzata (speċjalment jekk ir-riserva tal-mudullun qabel ma tinbeda l-kura tkun batuta), u partikularment f'pazjenti bl-għadd taċ-ċelluli CD4 inqas minn 100/mm3.
English: Tablet core:
Maltese: Pankreatite:
English: Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Pregnancy
Maltese: ANTIKONVULŻIVI
English: A bioequivalence study compared Combivir with lamivudine 150 mg and zidovudine 300 mg tablets taken together.
Maltese: Studju dwar bioekwivalenza qabbel lil Combivir ma' pilloli ta' 150 mg lamivudine u ta' 300mg zidovudine meħudin flimkien.
English: As only limited data available the clinical significance is unknown.
Maltese: Minħabba li hija disponibbli biss dejta limitata s-sinifikat kliniku mhux magħruf.
English: Dosage in the elderly: No specific data are available, however special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
Maltese: M'hemmx informazzjoni partikolaru disponibbli, iżda għal din il-kategorija trid tingħata attenzjoni speċjali minħabba bidliet assoċjati ma' l-eta' bħal tnaqqis fil-funzjoni tal-kliewi u tibdil ta' parametri ematoloġiċi.
English: URICOSURIC Probenecid/Lamivudine
Maltese: Probenecid/Lamivudine
English: Very rare side effects These may affect up to 1 in 10,000 people:
Maltese: Dawn jistgħu jaffettwaw sa persuna waħda minn kull 10,000:
English: ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS) Ranitidine/Lamivudine
Maltese: TAR-RIĊETTUR H1 TAL-ISTAMINA)
English: Immune Reactivation Syndrome: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: Sindromu ta' Rijattivazzjoni Immunitarja: f'pazjenti infettati bl-HIV, b'defiċjenza immunitarja severa fiż-żmien li tkun inbdiet it-terapija antiretrovirali kkombinata (TARK), jista' jkun hemm reazzjoni nfjammatorja bla sintomi għall-mikrobi opportunistiċi jew residwali li jwasslu għall-kundizzjonijiet kliniċi serji, jew li sintomi jmorru għall-agħar.
English: Active renal secretion of lamivudine in the urine is mediated through organic cation transporters (OCTs); co-administration of lamivudine with OCT inhibitors or nephrotoxic drugs may increase lamivudine exposure.
Maltese: Tneħħija attiva ta' lamivudine mill-kliewi għal ġol-awrina hija medjata permezz ta' trasportaturi ta' katjoni organiċi (OCTs); l-għoti ta' lamivudine ma' impedituri ta' OCT jew ma' mediċini nefrotossiċi jista' jżid l-esponiment għal lamivudine.
English: The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue-DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Maltese: L-istudju wera li feti esposti in utero għat-taħlita spiċċaw b'livell ogħla ta' analogi nukleosidi inkorporati ma' DNA f'organi multipli tal-feti, u wera sinjali ta' telomere iqsar minn dawk esposti biss għal zidovudine.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains lamivudine 150 mg zidovudine 300 mg
Maltese: Kull pillola miksija b'rita fiha lamivudine 150 mg zidovudine 300 mg
English: HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral reverse transcriptase (RT).
Maltese: Ir-reżistenza ta' HIV-1 għal lamivudine tinvolvi l-iżvilupp ta' bidla fl-aċidu amino M184V qrib is-sit attiv tar-reverse transcriptase tal-virus (RT).
English: Weight and metabolic parameters: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Maltese: Piż u parametri metaboliċi:Matul terapija antiretrovirali tista' sseħħ żieda fil-piż u fil-livelli ta' lipidi u glukożju fid-demm.
English: Lactic acidosis is a rare but serious side effect
Maltese: Effetti sekondarji rari ħafna
English: A pilot study has demonstrated that zidovudine is incorporated into leukocyte nuclear DNA of adults, including pregnant women, taking zidovudine as treatment for HIV-1 infection, or for the prevention of mother to child viral transmission.
Maltese: Studju bi prova wera li zidovudine jiġi nkorporat fid-DNA nukleari ta' lewkoċiti f'adulti,inklużi nisa tqal, li jkunu qed jieħdu zidovudine għall-kura ta' l-infezzjoni HIV-1, jew biex il-virus ma jitħalliex jgħaddi mill-omm għall-wild.
English: High doses of trimethoprim/ sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis have not been studied and should be avoided.
Maltese: Pneumocystis jirovecii (PCP) u toxoplasmosis għadhom ma ġewx studjati u għandhom jiġu evitati.
English: ANTIMYCOBACTERIALS Rifampicin/Lamivudine
Maltese: Rifampicin/Lamivudine
English: Patients co-infected with hepatitis C virus: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.5).
Maltese: Mhuwiex rakkomandat l-użu flimkien ta' ribavirin ma' zidovudine minħabba riskju akbar ta' anemija (ara sezzjoni 4.5) Ostejonekrożi:
English: Caution should be exercised when administering zidovudine to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Maltese: Għandha tingħata attenzjoni meta jingħataw zidovudine lil pazjenti (partikolarment nisa ħoxnin) li jbatu minn epatomegalija, epatite jew fatturi oħra ta' riskji magħrufa għal mard tal-fwied u steatożi epatika (inklużi xi prodotti mediċinali u alkoħol).
English: Lamivudine: AUC ↑40% Trimethoprim: AUC ↔ Sulfamethoxazole: AUC ↔ (organic cation transporter inhibition)
Maltese: X'inhu Combivir u għalxiex jintuża Combivir jintuża biex jikkura l-infezzjoni bl-HIV (virus tal-immunodefiċjenza umana) fl-adulti u fit-tfal.
English: From studies with intravenous zidovudine, the mean terminal plasma half-life was 1.1 hours and the mean systemic clearance was 1.6 l/h/kg.
Maltese: Fi studji dwar l-għoti ta' ziduvidine minn ġol-vina , il-half-life terminali tal-plażma kienet ta' 1.1
English: Signs of osteonecrosis include:
Maltese: Sinjali ta' ostejonekrożi jinkludu:
English: Uncommon: Transient rises in liver enzymes (AST, ALT) Rare: Hepatitis
Maltese: Mhux komuni: żieda mhux permanenti fil-livelli ta' l-enzimi tal-fwied (AST, ALT).
English: Oral use bottle (HDPE)
Maltese: Għall-użu għall-ħalq flixkun (HDPE)
English: MA (EU) number (Invented) name
Maltese: Numru MA (UE) Isem (ivvintat) Qawwa Għamla Farmaċewtika Mod ta' kif għandu jingħata
English: Pack size
Maltese: Imballaġġ Primarju Daqs talpakkett
English: Film-coated tablet
Maltese: Pilloli miksija b'rita
English: The full EPAR for Rasagiline Mylan 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: The active substance in Rasagiline Mylan, rasagiline, is a ‘monoamine oxidase B inhibitor'.
Maltese: Is-sustanza attiva f'Rasagiline Mylan, ir-rasagilina, hija ‘inibitur tal-monoamina ossidazi B'.
English: Rasagiline Mylan is a ‘generic medicine'.
Maltese: Rasagiline Mylan huwa ‘mediċina ġenerika'.
English: Dopamine is important for controlling movement and coordination.
Maltese: Iddopamina hija importanti għall-kontroll tal-moviment u l-koordinazzjoni.
English: Rasagiline Mylan is available as tablets (1 mg).
Maltese: Rasagiline Mylan jiġi bħala pilloli (1 mg)
English: Rasagiline Mylan contains the active substance rasagiline.
Maltese: Rasagiline Mylan fih is-sustanza attiva rasagilina.
English: Rasagiline Mylan rasagiline
Maltese: Informazzjoni oħra dwar Rasagiline Mylan
English: Rasagiline Mylan is a medicine used to treat adults with Parkinson's disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Maltese: Rasagiline Mylan huwa mediċina li tintuża fil-kura tal-adulti bil-marda ta' Parkinson (disturb progressiv fil-moħħ li jikkawża rogħda, dewmien fil-movimenti u ebusija tal-muskoli).
English: This is a summary of the European public assessment report (EPAR) for Rasagiline Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rasagiline Mylan.
English: It blocks the enzyme monoamine oxidase type B, which breaks down a substance called dopamine in the brain.
Maltese: Din timblokka l-enzima monoamina ossidazi tat-tip B, li tkisser sustanza li tissejjaħ dopamina fil-moħħ.
English: Why is Rasagiline Mylan approved?
Maltese: Għaliex ġie approvat Rasagiline Mylan?
English: By increasing levels of dopamine in the parts of the brain that control movement and coordination, Rasagiline Mylan reduces the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Maltese: Biżżieda ta' livelli ta' dopamina fil-partijiet tal-moħħ li jikkontrollaw il-moviment u l-koordinazzjoni, Rasagiline Mylan inaqqas is-sintomi tal-marda ta' Parkinson, bħall-ebusija u dewmien fil-movimenti.
English: Because Rasagiline Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Azilect.
Maltese: Minħabba li Rasagiline Mylan huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet biex tiġi ddeterminata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Azilect.
English: Because Rasagiline Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Rasagiline Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: This means that Rasagiline Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Azilect.
Maltese: Dan ifisser li Rasagiline Mylan huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Azilect.
English: What are the benefits and risks of Rasagiline Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Rasagiline Mylan?
English: A risk management plan has been developed to ensure that Rasagiline Mylan is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Rasagiline Mylan jintuża bl-aktar mod sigur possibbli.
English: The Committee recommended that Rasagiline Mylan be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Rasagiline Mylan ikun approvat għall-użu fl-UE.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rasagiline Mylan has been shown to have comparable quality and to be bioequivalent to Azilect.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Rasagiline Mylan wera li għandu kwalità komparabbli u huwa bijoekwivlenti għal Azilect.
English: Rasagiline Mylan can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having fluctuations in the control of their condition.
Maltese: Rasagiline Mylan jista' jintuża kemm waħdu, jew bħala żieda ma' levodopa (mediċina oħra użata għallmarda tal-Parkinson) f'pazjenti li jkollhom fluttwazzjonijiet fil-kontroll tal-kundizzjoni tagħhom.
English: Fluctuations happen when the effects of the medication wear off and symptoms re-emerge before the next dose is due.
Maltese: Ilfluttwazzjonijiet iseħħu meta l-effetti tal-mediċina ma jibqgħux jinħassu u s-sintomi jfeġġu mill-ġdid qabel id-doża li jmiss.
English: How has Rasagiline Mylan been studied?
Maltese: Kif ġie studjat Rasagiline Mylan?
English: They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Maltese: Dawn huma relatati ma' tnaqqis fl-effett ta' levodopa, meta l-pazjent jesperjenza bidliet għall-għarrieda bejn stat ta' ‘on' u li fih ikun kapaċi jimxi, u stat ta' ‘off' li fih ikollu diffikultà biex jimxi.
English: Intramuscular use vial (glass)
Maltese: Użu għal ġol-muskoli kunjett (ħġieġ)
English: Stargen Ltd Favierou 48 Athens 10438 Greece
Maltese: Stargen Ltd Favierou 48 Athens 10438
English: ANNEX III CONDITION FOR THE LIFTING OF THE SUSPENSION
Maltese: ANNESS III KUNDIZZJONI GĦAT-TNEĦĦIJA TAS-SUSPENSJONI
English: Norma Hellas S.A. Menandrou 54 Athens 10431
Maltese: Norma Hellas S.A. Menandrou 54