FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials involving the administration of 7,350 doses of PROCOMVAX to 2,993 healthy infants 6 weeks to 15 months of age, PROCOMVAX was generally well tolerated.
Maltese: Fi provi kliniċi li kienu jinvolvu l-għoti ta' 7,350 doża ta' PROCOMVAX lil 2,993 tarbija b'saħħitha ta' bejn 6 ġimgħat u 15-il xahar, PROCOMVAX ġeneralment kien ittollerat tajjeb.
English: At 12 to 15 months of age, PROCOMVAX may be given simultaneously with Merck MMR (Measles, Mumps, and Rubella Virus Vaccine Live), or OPV or with a booster dose of diphtheria, tetanus, acellular pertussis vaccine (DTaP) at 15 months of age in children who received the primary series of DTP.
Maltese: Ta' 12 sa 15-il xahar, PROCOMVAX jista' jingħata simultanjament ma' Merck MMR (Vaċċin kontra l-Virus tal-Ħożba, Gattone u Rubella Ħaj), jew OPV jew ma' doża booster tal-vaċċin kontra d-difterite, tetnu u sogħla konvulsiva (DTaP) fi tfal li jkunu rċevew is-serje primarja ta' DTP.
English: In these studies, 618 infants had anti-HBs results available following the first 2 doses of PROCOMVAX and 461 had anti-HBs results available following the third dose of PROCOMVAX.
Maltese: F'dawn l-istudji, 618-il tarbija kellhom riżultati anti-HBs disponibbli wara l-ewwel 2 dożi ta' PROCOMVAX u 461 kellhom riżultati anti-HBs disponibbli wara t-tielet doża ta' PROCOMVAX.
English: Rare
Maltese: JIS
English: - elevation of liver enzymes, fatigue, fever, malaise, influenza-like symptoms, bronchospasm-like symptoms, serum sickness, thrombocytopenia - dizziness, headache, paresthesia - nausea, vomiting, diarrhea, abdominal pain - arthralgia, myalgia - rash, pruritus, - hypotension, syncope - paralysis (Bell's palsy), neuropathy, neuritis (including Guillain Barre Syndrome, myelitis including transverse myelitis), encephalitis, optical neuritis.
Maltese: - żieda fl-enżimi tal-fwied, għeja, deni, telqa, sintomi bħal ta' l-influwenza, sintomi jixbħu spażmu tal-bronki, mard mis-serum, tromboċitopenja
English: These infants nominally received PROCOMVAX at 2-3, 4-5, and 12-15 months of age
Maltese: Dawn it-trabi rċevew b'mod nominali PROCOMVAX ta' 2-3, 4-5, u 12-15 -il xahar.
English: Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC 7.5 µg
Maltese: Polyribosylribitol phosphate (PRP) minn Haemophilus influenzae tat-tip b bħala PRP-OMPC 7.5 µg Neisseria meningitidis OMPC (kumpless tal-proteina tal-membrana ta' barra
English: PROCOMVAX may not induce protective antibody levels immediately following vaccination and may not result in a protective antibody response in all individuals given the vaccine.
Maltese: PROCOMVAX jista' ma jipproduċix livelli ta' protezzjoni ta' anti-korpi immedjatament wara ttilqima u jista' ma jirriżultax f'risposta protettiva ta' anti-korpi f'kull persuna li tingħata l-vaċċin.
English: In these studies, 2121 infants had anti-PRP results available following the first 2 doses of PROCOMVAX and 1768 had anti-PRP results available following the third dose of PROCOMVAX.
Maltese: F'dawn l-istudji, 2121 tarbija kellhom riżultati anti-PRP disponibbli wara l-ewwel żewġ dożi ta' PROCOMVAX u 1768 kellhom riżultati anti-PRP disponibbli wara t-tielet doża ta' PROCOMVAX.
English: 1 single dose 0.5 ml in vial.
Maltese: Doża waħda ta' 0.5 ml f'kunjett.
English: Other side effects include irritability, sleepiness, fever, diarrhoea, vomiting, loss of appetite, middle ear infection, and unusual high-pitched crying.
Maltese: Effetti sekondarji oħra jinkludu l-irritabilità, ħedla ta' ngħas, deni, dijarea, rimettar, telf ta' l-aptit, infezzjoni tal-widna tan-nofs, u biki jgħajjat mhux tas-soltu.
English: Suspension for injection in vial.
Maltese: Suspensjoni għal injezzjoni f'kunjett.
English: Post-dose 2, 95 % to 99 % of infants developed > 0.15 µg/ml of anti-PRP, a level associated with short-term protection against invasive Hib disease, and the GMTs ranged from 2.5 µg/ml to 4.3 µg/ml.
Maltese: Wara t-tieni doża, 95% sa 99% tat-trabi żviluppaw > 0.15 µg/ml ta' anti-PRP, livell assoċjat ma' protezzjoni fuq perjodu qasir kontra mard invażiv ta' l-Hib, u l-GMTs varjaw minn 2.5 µg/ml sa
English: PROCOMVAX suspension for injection in vial.
Maltese: PROCOMVAX suspensjoni għal injezzjoni f'kunjett.
English: Across all three doses of PROCOMVAX, there were no significant differences in the frequency of adverse experiences between PROCOMVAX and the monovalent vaccines Merck PRPOMPC Vaccine and Merck Hepatitis B (Recombinant) Vaccine.
Maltese: Bejn it-tliet dożi ta' PROCOMVAX, ma kienx hemm differenzi sinifikanti fil-frekwenza ta' l-esperjenzi avversi bejn PROCOMVAX u lvaċċini monovalenti Merck PRP-OMPC Vaccine u Merck Hepatitis B (Recombinant) Vaccine.
English: However, the frequency of irritability was statistically higher after all three injections of PROCOMVAX combined and after the first injection of PROCOMVAX compared to the monovalent vaccines.
Maltese: Madankollu, il-frekwenza ta' l-irritabilità kienet statistikament ogħla wara t-tliet injezzjonijiet ta' PROCOMVAX magħqudin u wara l-ewwel injezzjoni ta' PROCOMVAX meta mqabbel mal-vaċċini monovalenti.
English: PROCOMVAX will not protect against invasive disease caused by Haemophilus influenzae other than type b or against invasive disease (such as meningitis or sepsis) caused by other microorganisms.
Maltese: PROCOMVAX ma jipproteġix kontra mard invażiv ikkawżat minn Haemophilus influenzae ħlief ta' tip b jew kontra mard invażiv (bħal meninġite jew sepsis) ikkawżat minn mikro-organiżmi oħra.
English: - lymphadenopathy.
Maltese: TAL-PRODOTT MEDIĊINALI
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Maltese: Għandu jitqies ir-riskju potenzjali ta' apneja kif ukoll il-ħtieġa għal monitoraġġ respiratorju għal 48-72h meta s-serje ta' immunizzazzjoni primarja tingħata lil trabi prematuri ħafna (li jitwieldu ≤ 28 ġimgħa ta' ġestazzjoni) u b'mod partikolari għal dawk bi storja preċedenti ta' immaturità respiratorja.
English: 0.5 ml suspension in vial (type I flint glass).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 0.5 ml sospensjoni f'kunjett (ħġieġ żniedi ta' tip I).
English: Local reactions at injection site: transient soreness, erythema, induration
Maltese: Reazzjonijiet lokali fil-post ta' l-injezzjoni: uġigħ għaddien, eritema, ebusija
English: Of these infants, 1,177 were involved in clinical trials in which most received PROCOMVAX concomitantly with other licensed paediatric vaccines.
Maltese: Minn dawn it-trabi, 1,177 kienu involuti fi provi kliniċi li fihom, il-maġġoranza ngħataw PROCOMVAX flimkien ma' vaċċini pedjatriċi oħra lliċenzjati.
English: These components are the Haemophilus influenzae type b capsular polysaccharide (PRP) that is covalently bound to an outer membrane protein complex (OMPC) of Neisseria meningitidis and hepatitis B surface antigen (HBsAg) from recombinant yeast cultures.
Maltese: Dawn ilkomponenti huma l-polisakkarid kapsulari (PRP) ta' Haemophilus influenzae tat-tip b li huwa marbut b'mod kovalenti ma' kumpless ta' proteini tal-membrana esterna (OMPC - outer membrane protein complex) tan-Neisseria meningitides u antiġen tal-wiċċ ta' l-epatite B (HBsAg) minn kulturi
English: Anti-HBs Responses to PROCOMVAX in Infants Previously Vaccinated with Hepatitis B Vaccine
Maltese: Reazzjonijiet anti-HBs għal PROCOMVAX fi Trabi Mlaqqma Qabel b'Vaċċin kontra l-Epatite B
English: Immunogenicity results from open-labeled studies indicate that PROCOMVAX can be administered concomitantly with DTP (Diphtheria, Tetanus and whole cell Pertussis vaccine), OPV (Oral Poliomyelitis vaccine), IPV ( inactivated poliomyelitis vaccine) and Merck MMR (Measles, Mumps,
Maltese: Riżultati ta' l-immunoġeniċità minn studji b'tikketta mikxufa jindikaw li PROCOMVAX jista' jingħata flimkien mad-DTP (Difterite, Tetnu u vaċċin ta' ċellola sħiħa kontra l-Pertussis [sogħla konvulsiva]), OPV (Vaċċin Orali tal-Poljomelite), IPV (vaċċin inattivat tal-poljomelite) u Merck MMR (Ħożba, Gattone, u Vaċċin tal-Virus tar-Rubella Ħaj) bl-użu ta' siti għall-injezzjoni u siringi separati għal vaċċini li jistgħu jiġu injettati.
English: In addition, a variety of adverse effects have been reported with marketed use of either Merck PRPOMPC Vaccine or Merck Hepatitis B (Recombinant) Vaccine in infants and children through 71 months of age.
Maltese: Barra minn hekk, kienu rrapportati varjetà ta' effetti avversi bl-użu kummerċjalizzat ta' Merck PRPOMPC Vaccine jew Merck Hepatitis B (Recombinant) Vaccine fi trabi u tfal li kellhom sa 71 xahar.
English: Like all medicines, PROCOMVAX can have side effects.
Maltese: Bħal kull mediċina oħra, PROCOMVAX jista' jkollu effetti sekondarji.
English: Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Maltese: F'4 studji kliniċi li saru bejn l-1992 u l-2000, PROCOMVAX ġie mogħti lil 722 tarbija, ta' madwar xahrejn, li kienu ngħataw doża waħda tal-vaċċin kontra l-epatite B malli twieldu.
English: Merck Sharp & Dohme OÜ Tel: +372.613.9750
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204201
English: The vaccine may not prevent
Maltese: Il-vaċċin jista' ma jwaqqafx
English: In these studies, 1503 infants had anti-HBs results available following the first 2 doses of PROCOMVAX and 1309 had anti-HBs results available following the third dose of PROCOMVAX.
Maltese: HBs disponibbli wara l-ewwel 2 dożi ta' PROCOMVAX u 1309 kellhom riżultati kontra
English: Infants born of HBsAg-positive mothers should receive Hepatitis B Immune Globulin and Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
Maltese: Immunitarja ta' Epatita B u Vaċċin kontra l-Epatite B (Rikombinanti) meta jitwieldu u għandhom ikomplu s-sensiela tattilqimiet kontra l-epatite B.
English: In 4 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 1809 infants, approximately 2 months of age, who had not previously received any hepatitis B vaccine.
Maltese: F'4 studji kliniċi li saru bejn l-1992 u l-2000, PROCOMVAX ġie mogħti lil 1809 tarbija, ta' madwar xahrejn, li ma kienu ngħataw l-ebda vaċċin kontra l-epatite B qabel.
English: - if you are a hepatitis B virus surface antigen (HBsAg)-positive mother, your infant should receive Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
Maltese: - jekk inti omm pożittiva għall-antiġen tal-wiċċ tal-virus ta' l-epatite B (HBsAg), it-tarbija tiegħek għandha tirċievi Globulina Immunitarja ta' l-Epatite B (HBIG) u vaċċin kontra l-epatite B (rikombinanti) meta jitwieldu u għandhom ikomplu s-sensiela tat-tilqimiet kontra l-epatite B.
English: 7.5 µg of PRP from Haemophilus influenzae type b as PRP-OMPC 125 µg of Neisseria meningitidis OMPC 5.0 µg of hepatitis B surface antigen produced in recombinant yeast cells
Maltese: 7.5 µg ta' PRP minn Haemophilus influenzae tip b bħala PRP-OMPC 5.0 µg ta' antiġen tal-wiċċ ta' l-epatite B prodott f'ċelloli tal-ħmira rikombinanti
English: Haematologic/Lymphatic Lymphadenopathy
Maltese: MANIFATTUR TAS-SUSTANZI BIJOLOĠIĊI ATTIVI
English: Merck Sharp & Dohme, inovativna zdravila d.o.o.
Maltese: Slovenská republika Merck Sharp & Dohme IDEA, Inc.
English: PROCOMVAX is indicated to help protect your child against invasive disease caused by Haemophilus influenzae type b (infection of brain and spinal cord tissues, infection of the blood, etc.) and against infection of the liver caused by all known subtypes of hepatitis B virus.
Maltese: PROCOMVAX huwa indikat biex jipproteġi aħjar lit-tifel/tifla tiegħek kontra mard invażiv ikkawżat minn Haemophilus influenzae tat-tip b (infezzjoni tat-tessuti tal-moħħ u tan-nerv li jgħaddi minn ġossinsla, infezzjoni tad-demm, eċċ.) u kontra infezzjoni tad-demm ikkawżata mis-sottotipi magħrufa kollha tal-virus ta' l-epatite B.
English: These infants nominally received PROCOMVAX at 2, 4, and 12-15 months of age.
Maltese: Dawn it-trabi rċevew b'mod nominali PROCOMVAX ta' 2, 4 u 12-15 -il xahar.
English: Posology
Maltese: ISEM
English: In 6 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 2528 infants, approximately 2 months of age, who had not previously received any Hib vaccine.
Maltese: F'6 studji kliniċi li saru bejn l-1992 u l-2000, PROCOMVAX ġie mogħti lil 2528 tarbija, ta' madwar xahrejn, li ma kienu ngħataw l-ebda vaċċin kontra l-Hib qabel.
English: Other side effects that may occur rarely and be serious include seizure, febrile seizure, allergic reactions, allergic swelling (angioedema) and certain severe types of rash, injection site nodule.
Maltese: Effetti sekondarji oħra li jistgħu jseħħu b'mod rari u jkunu serji jinkludu aċċessjonijiet, aċċessjonijiet bid-deni, reazzjonijiet allerġiċi, tinfiħ allerġiku (anġjoedema) u ċerti tipi akuti ta' raxxijiet, għoqda fil-post ta' linjezzjoni.
English: PROCOMVAX has been administered simultaneously with the primary series of DTaP and enhanced inactivated poliovirus vaccine (IPV) to a limited number of infants.
Maltese: PROCOMVAX ingħata simultanjament mas-serje primarja ta' DTaP u ma' vaċċin mhux attivat aktar b'saħħtu kontra l-poljo (IPV) lil numru limitat ta' trabi.
English: POSSIBLE SIDE EFFECTS
Maltese: EFFETTI
English: Batch
Maltese: B.
English: Liquid Merck PRP-OMPC Vaccine
Maltese: TA' KIF JINGĦATA Prodott mediċinali jingħata bir-riċetta tat-tabib
English: SANOFI PASTEUR MSD SNC Tél: +33.4.37.28.40.00
Maltese: Tél: +33.4.37.28.40.00
English: PROCOMVAX must be injected into the muscle of the thigh.
Maltese: Hbs disponibbli wara t-tielet doża ta' PROCOMVAX.
English: Name and address of the manufacturer of the biological active substances
Maltese: Isem u indirizz tal-manifatturi tas-sustanzi bijoloġiċi attivi
English: INSTRUCTIONS ON USE
Maltese: Esperjenza wara t-tqegħid fis-suq
English: PROCOMVAX
Maltese: Ireland SANOFI
English: • The CHMP considered the referral under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing fenofibrate, bezafibrate, ciprofibrate and gemfibrozil.
Maltese: • Is-CHMP ikkunsidra r-riferiment magħmul skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, għall-prodotti mediċinali li fihom fenofibrate, bezafibrate, ciprofibrate u gemfibrozil.
English: Fibrates have been shown to reduce plasma triglycerides (TG) by 30% to 50% and raise the level of high density lipoprotein cholesterol (HDL-C) by 2% to 20%.
Maltese: Il-fibrati ntwerew li jnaqqsu t-trigliċeridi tal-plasma (TG) bi 30% sa 50% u li jgħollu l-livell tal-kolesterol tal-lipoproteini b'densità għolja (HDL-C) bi 2% sa 20%.
English: • The CHMP considered additional published data for the fibrates, including results of the ACCORD lipid trial which were supportive of the use of fenofibrate (100, 300, 67, 200, 250 mg capsules and 160 and 145 mg film coated tablets) as add on therapy to a statin in patients with mixed hyperlipidaemia at high cardiovascular risk when triglycerides and HDL cholesterol are not adequately controlled with a statin alone.
Maltese: • Is-CHMP ikkunsidra dejta ippubblikata addizzjonali għall-fibrati, inkluż ir-riżultati tal-prova tal-lipidi ACCORD li kienu ta' appoġġ għall-użu ta' fenofibrate (kapsuli ta' 100, 300, 67, 200, 250 mg u pillolii miksija b'rita ta' 160 u 145 mg) bħala terapija miżjuda ma' statin f'pazjenti b'iperlipidimja mħallta b'riksju kardjovaskulari għoli meta t-trigliċeridi u l-kolesterol HDL mhumiex ikkontrollati b'mod adegwat bi statin biss.
English: Fibrates (fenofibrate, bezafibrate, ciprofibrate and gemfibrozil) are a class of lipid-lowering drugs and exert their effects mainly by activating the peroxisome proliferator-activated receptor-alpha (PPARalpha), apart from bezafibrate which is an agonist for all three PPAR isoforms alpha, gamma, and delta.
Maltese: Il-fibrati (fenofibrate, bezafibrate, ciprofibrate u gemfibrozil) huma klassi ta' mediċini li jbaxxu lammont ta' lipidi u jeżerċitaw l-effetti tagħhom l-aktar billi jattivaw ir-riċettur-alpha attivat b'peroxisome proliferator (PPAR-alpha), apparti bezafibrate, li huwa agonista għat-tliet PPAR isoforms kollha alpha, gamma u delta.
English: The long term efficacy and safety of the currently licensed fibrates has mainly been examined in six large randomised, placebo controlled trials: the Helsinki Heart Study (HHS) and Veterans Affairs HDL Intervention Trial (VA-HIT) with gemfibrozil, the Bezafibrate Infarction Prevention (BIP) Study and the Lower Extremity Arterial Disease Event Reduction (LEADER) Study with bezafibrate, the Fenofibrate Intervention in Event Lowering in Diabetes (FIELD) Study and the Action to Control Cardiovascular Risk in Diabetes study (ACCORD) with fenofibrate.
Maltese: Study u l-Lower Extremity Arterial Disease Event Reduction (LEADER) Study b'bezafibrate, il-Fenofibrate Intervention in Event Lowering in Diabetes (FIELD) Study u l-Action to Control Cardiovascular Risk in Diabetes study (ACCORD) b'fenofibrate.
English: No randomised, controlled trial data are available for ciprofibrate, but differences across the class in surrogate marker effects have not been shown.
Maltese: Għal ciprofibrate, m'hemm l-ebda dejta minn prova ikkontrollata randomizzata, iżda ma ntweriet l-ebda differenza tul il-klassi fl-effetti tal-markaturi surrogati.
English: However, for certain doses of fenofibrate (100, 300, 67, 200, 250 mg capsules and 160 and 145 mg film coated tablets), results from ACCORD lipid trial, taken together with previous outcome studies and fibrate trials meta-analyses support a benefit of add on therapy in the dyslipidaemic population, when triglycerides and HDL cholesterol are not adequately controlled with a statin alone.
Maltese: Madankollu, għal ċerti dożi ta' fenofibrate (kapsuli ta' 100, 300, 67, 200, 250 mg u pilloli miksija b'rita ta' 160 u 145 mg), ir-riżultati minn prova tal-lipidi ACCORD, meħudin flimkien ma' studji preċedenti b'riżultati u l-meta-analiżi minn provi tal-fibrati jappoġġjaw il-benefiċċju ta' terapija miżjuda fil-popolazzjoni dislipidemika, meta t-trigliċeridi u l-kolesterol HDL mhumiex ikkontrollati b'mod adegwat bi statin biss.
English: Overall summary of the scientific evaluation of fenofibrate, bezafibrate, ciprofibrate and gemfibrozil containing medicinal products (see Annex I)
Maltese: III għall-prodotti mediċinali li fihom fenofibrate, bezafibrate, ciprofibrate u gemfibrozil (ara l-Anness I).
English: • The CHMP considered the PhVWP recommendations on the review of the benefit risk of fibrates in the treatment of cardiovascular (mortality and morbidity) and dyslipidaemic diseases.
Maltese: • Is-CHMP ikkunsidra r-rakkomandazzjonijiet tal-PhVWP dwar ir-reviżjoni tal-benefiċċju/riskju talfibrati fit-trattament tal-mard kardjovaskulari (mortalità u morbidità) u dislipidemiku.
English: The fibrates share a common mechanism of action and exert qualitatively similar effects on serum lipid triglycerides (decrease) and HDL-cholesterol concentrations (increase).
Maltese: Il-fibrati jiskambjaw mekkaniżmu ta' azzjoni komuni u jeżerċitaw effetti simili mil-lat kwalitattiv fuq ittrigliċeridi lipidi tas-serum (tnaqqis) u l-konċentrazzjonijiet tal-kolesterol-HDL (żieda).
English: Also recognizing that trials have provided evidence that gemfibrozil may differ from the rest of the class and may have a more favourable profile it was felt that a differentiation in the given indications for gemfibrozil was justified to also include treatment of primary hypercholesterolaemia and primary prevention of cardiovascular morbidity in males when a statin is contraindicated or not tolerated.
Maltese: Barra minn hekk, waqt li ġie rikonoxxut li l-provi ipprovdew evidenza li gemfibrozil jista' jkun differenti mill-kumplament tal-klassi u jista' jkollu profil aktar favorevoli, inħass li divrenzjar fl-indikazzjonijiet mogħtija għal gemfibrozil kien iġġustifikat li jinkludi wkoll trattament ta' iperkolesterolimja primarja u prevenzjoni primarja ta' morbidità kardjovaskulari fl-irġiel meta statin huwa kontra-indikat jew mhux ittollerat.
English: • The CHMP concluded from the data provided that there is a lack of therapeutic efficacy in the primary or secondary prevention of cardiovascular disease for all fibrates, with the exception of gemfibrozil which showed benefit on primary prevention of cardiovascular morbidity in males when a statin cannot be used.
Maltese: • Mid-dejta pprovduta, is-CHMP ikkonkluda li hemm nuqqas ta' effikaċja terapewtika fil-prevenzjoni primarja jew sekondarja tal-mard kardjovaskulari għall-fibrati kollha, bl-eċċezzjoni ta' gemfibrozil li wera benefiċċju fuq il-prevenzjoni primarja tal-morbidità kardjovaskulari f'irġiel meta statin ma jkunx jista' jintuża.
English: the CHMP has recommended the variation of the marketing authorisation for which the relevant sections of the summaries of product characteristics and package leaflets are set out in Annex III for medicinal products containing fenofibrate, bezafibrate, ciprofibrate and gemfibrozil (see Annex I).
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali li fihom fenofibrate, bezafibrate, ciprofibrate u gemfibrozil (ara l-Anness I)
English: Based on the above data, it was concluded that the product information for all fibrates should be updated to reflect the available evidence and current clinical practice, and define groups of patients that were more likely to derive benefit from fibrates such as patients with severe hypertriglyceridaemia with or without low HDL cholesterol or with mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
Maltese: Skont id-dejta t'hawn fuq, ġie konkluż li l-informazzjoni dwar il-prodott għall-fibrati kollha għandha tiġi aġġornata biex tirrifletti l-evidenza disponibbli u l-prattika klinika attwali, u tiddefinixxi l-gruppi ta' pazjenti li kellhom aktar probabbiltà li jieħdu benefiċċji mill-fibrati bħal pereżempju pazjenti b'ipertrigliċeridemija bi u mingħajr kolesterol HDL baxx jew b'iperlipidemija mħallta meta statin huwa kontraindikat jew mhux tollerat.
English: In this regard, the Pharmacovigilance Working Party (PhVWP) review of all available data on the benefit risk of fibrates in the treatment of cardiovascular (mortality and morbidity) and dyslipidaemic diseases, as initially endorsed by the CHMP, concluded that in most cases, the indications for fibrates had been granted mainly on the basis of their effects on these surrogate parameters and that little evidence was available on the effects of the different fibrates on cardiovascular morbidity and mortality.
Maltese: F'dan ir-rigward, ir-reviżjoni tal-Grupp ta' Ħidma tal-Farmkoviġilanza (PhVWP) tad-dejta disponibbli kollha dwar ilbenefiċċju/riskju tal-fibrati fit-trattament ta' mard kardjovaskulari (mortalità u morbidità) u dislipidemiku, kif inizjalment approvati mis-CHMP, ikkonkluda li f'ħafna każijiet, l-indikazzjonijiet għallfibrati ingħataw l-aktar fuq il-bażi tal-effetti fuq dawn il-parametri sostituti u li kien hemm ftit dejta disponibbli fuq l-effetti tal-fibrati differenti fuq il-morbidità u l-mortalità kardjovaskulari.
English: ATC code: A16AB07.
Maltese: A16AB07.
English: 6-Minute Walk Test Distance (meters)
Maltese: Distanza fit-Test tal-Mixja ta' 6 minuti (metri)
English: Date of first authorisation: 29 March 2006 Date of latest renewal: 29 March 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 29 ta' Marzu, 2006 Data tal-aħħar tiġdid: 29 ta' Marzu, 2011
English: Name and address of the manufacturers of the biological active substance Genzyme Corporation 45, 51, 76, 74 and 80 New York Avenue, Framingham, MA 01701, United States
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva Genzyme Corporation 45, 51, 76, 74 and 80 New York Avenue, Framingham, MA 01701, L-Istati Uniti
English: Manufacturer Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Maltese: Manifattur Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, L-Irlanda
English: System Organ Class
Maltese: Klassi tal-Organi tas-Sistema