FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Maltese: • Is-Sistema ta' Mikro-Injezzjoni għal injezzjoni minn ġol-ġilda tikkonsisti f'siringa mimlija għall-lest b'labra mikro (1.5 mm) u sistema tal-protezzjoni tal-labra.
English: The Western Blot technique disproves the false-positive ELISA test results.
Maltese: It-teknika Western Blot tgiddeb ir-riżultati tat-test ELISA li jkunu pożittivi-foloz.
English: Flange
Maltese: Flanġ
English: Organ class
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: - Tell your doctor if you have been treated with medicines that may reduce your immune response such as corticosteroids (for example cortisone), medicines against cancer (chemotherapy), radiotherapy or other medicines affecting the immune system.
Maltese: - Għid it-tabib tiegħek jekk kont ikkurat b'mediċini li jistgħu jnaqqsu r-rispons immuni tiegħek bħal kortikosterojdi (per eżempju cortisone), mediċini kontra l-kanċer (kimoterapija), radjuterapija jew mediċini oħrajn li jaffettwaw is-sistema immuni.
English: • Pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord or Guillain-Barré syndrome which causes
Maltese: • Uġigħ lokalizzat fir-rotta tan-nervaturi, konvulżjonijiet assoċjati ma' deni, disturbi tas-sistema nervuża li jinkludu infjammazzjoni tal-moħħ jew tas-sinsla,, jew is-sindrome ta' Guillain-Barré li jikkawża dgħjufija u paralisi estremi
English: In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of IDflu by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route.
Maltese: III, 2606 persuna l-fuq minn 60 sena, irċivew 0.1 ml ta' IDflu minn ġol-ġilda u 1089 persuni l-fuq minn 60 sena irċivew 0.5 ml ta' vaċċin ta' kontra l-influwenza inattivat trivalenti ġol-muskoli.
English: Paresthesia, neuritis
Maltese: Disturbi fis-sistema nervuża
English: IDflu may contain residues of eggs such as ovalbumin and residues of neomycin, formaldehyde and octoxinol 9, which are used during the manufacturing process (see section 4.3).
Maltese: IDflu jista jkun fih residwi ta' bajd bħal ovalalbumina u residwi ta' neomycin, formaldehyde u octoxinol 9 li jintużaw waqt il-proċess tal-maniffattura (ara sezzjoni 4.3)
English: Intradermal use
Maltese: Mhux Marufa
English: Transient thrombocytopenia, transient lymphadenopathy
Maltese: Tromboċitopenja li tgħaddi malajr, limfadenopatija temporanja
English: Sanofi Pasteur Sp. z o.o.
Maltese: Sanofi Pasteur
English: Reactions of not known frequency (frequency cannot be estimated from the available data) - Allergic reactions including skin reactions that may spread throughout the body such as hives, severe allergic reactions (anaphylactic reactions), swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe (angioedema), failure of the circulatory system
Maltese: Reazzjonijiet mhux magħrufa (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli) - Reazzjonijiet allerġiċi inkluz reazzjonijiet tal-ġilda li jistgħu jinfirxu mal-ġisem kollu bħal urtikarja, reazzjonijiet allerġiċi severi (reazzjonijiet anafilattiċi), nefħa fil-wiċċ, ilsien jew farinġi, diffikultà biex tibla', urtikarja u diffikultajiet biex tieħu n-nifs (anġjodema), kollass tassistema ċirkolatorja (xokk) li jwassal għal emerġenza medika
English: The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Maltese: Is-Sistema ta' Mikro-Injezzjoni għal injezzjoni minn ġol-ġilda tikkonsisti f'siringa mimlija għall-lest b'labra mikro (1.5 mm) u sistema tal-protezzjoni tal-labra.
English: Posology Individuals 60 years of age and over: 0.1 ml.
Maltese: Adulti minn 60 sena l-fuq: 0.1 ml Popolazzjoni Pediatra
English: In repeated-dose toxicity studies in rabbits there was no significant evidence of systemic toxicity.
Maltese: Studji dwar it-tossiċità meta jingħataw dożi ripetuti fil-fniek, ma kien hemm l-ebda evidenza ta' tossiċità sistemika.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus (inactivated, split) of the following strains*: A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A) .............................................................................................................................. 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) .............................................................................................................................. 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ..................... 15 micrograms HA**
Maltese: X-263B) ............................................................................................................................. 15 mikrogrammi HA** B/Brisbane/60/2008 - bħal razza (B/Brisbane/60/2008, tat-tip selvaġġ) ............ 15 mikrogrammi HA**
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il
English: What IDflu looks like and contents of the pack
Maltese: Id-dehra ta' IDflu u l-kontenuti tal-pakkett
English: Cherubino Ltd Tel.: +356 21 343270
Maltese: Vistor Tel : +354 535 7000
English: Allergic reactions including generalized skin reactions such as urticaria, anaphylactic reactions, angioedema, shock
Maltese: Reazzjonijiet allerġiċi inklużi reazzjonijiet ġeneralizzati talġilda bħal urtikarja, reazzjonijiet anafilattiċci, anġjodema xokk.
English: When an injection of IDflu is given, the immune system (body's natural defences) will develop
Maltese: Meta tingħata injezzjoni ta' IDflu, is-sistema immuni (id-difiża naturali tal-ġisem) ser tiżviluppa protezzjoni kontra l-infezzjoni mill-influwenza.
English: Overdose is unlikely to have any untoward effect.
Maltese: Effetti sekondarji possibbli
English: In this case, the
Maltese: NUMRU(I)
English: Sanofi Pasteur divize vakcín sanofi-aventis, s.r.o.
Maltese: Magyarország sanofi-aventis zrt Tel.:
English: Date of latest renewal: 24 February 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 24 Frar 2009
English: Name and address of the manufacturer(s) responsible for batch release
Maltese: U>MANIFATTUR(I) RESPONSABBLI GĦALL
English: • Vessel inflammation which may result in very rare cases in temporary kidney problems.
Maltese: • Infjammazzjoni tal-vini/arterji li tista' tirriżulta f'każijiet rari ħafna ta' problemi temporanji tal
English: Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and serious adverse reactions were collected during six months of follow-up for 2,974 subjects (population of two out of the three clinical trials).
Maltese: L-evalwazzjoni tas-sigurtà twettqet fil-pazjenti kollha matul l-ewwel 3 ġimgħat wara l-vaċċin u avvenimenti avversi serji nġabru matul sitt xhur ta' follow-up għal 2,974 pazjent (populazzjoni ta tnejn minn tlieta studji kliniċi)
English: IDflu is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection System in
Maltese: IDflu hu suspensjoni għall-injezzjoni f'siringa mimlija għall-lest ta' 0.1 ml b'Sistema ta'
English: Remove the needle cap from the
Maltese: STRUZZJONIJIET GĦALL-UŻU
English: IDflu is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of
Maltese: IDflu hu mill-inqas immunoġeniku daqs il-vaċċini komparatur ta' kontra l-influwenza inattivat trivalenti li jingħata ġol-muskoli għal kull waħda mit-3 razez tal-influwenza f'persuni ta' 60 sena jew
English: Micro-needle Window
Maltese: Val-de-Reuil Franza
English: The recommended site of administration is the region of the deltoid.
Maltese: Is-sit rakkomandat ta' l-għoti hi ż-żona tad-deltojd.
English: Uncommon reactions (may affect up to 1 in 100 people) - Tiredness, joint pain and increased sweating.
Maltese: Reazzjonijiet mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100)
English: IDflu is as immunogenic as the comparator trivalent adjuvanted (MF-59 containing) vaccine in terms of GMT for each of the 3 influenza strains with the SRH method and for 2 strains with the HI method.
Maltese: GMT għal kull wieħed mit-3 razez tal-influwenza bil-metodu SRH u għal 2 razez bil-metodu HI.
English: In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
Maltese: (GMTR) għall-antikorp anti-HA (imkejjel minn HI) kienu evalwati skond kriterji definiti minn qabel.
English: Vial (HDPE) 50 ml
Maltese: Vjala (HDPE) 50 ml
English: Inactivated Schmallenberg virus, strain BH80/11-4: ≥ 1 RP*/2 ml (for cows) or ≥ 1 RP*/ml (for sheep).
Maltese: --1 Strejn BH80/11-4 tal-virus ta' Schmallenberg inattivat: ≥ 1 RP*/2 ml (għal baqar) or ≥ 1 RP*/ml (għan-nagħaġ).
English: EU/2/14/178/001 Zulvac SBV --1 Suspension for injection
Maltese: EU/2/14/178/001 Zulvac
English: 1 vial
Maltese: Vjala 1 Xejn
English: * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species.
Maltese: *Qawwa relattiva (test ta' qawwa fil-ġrieden) imqabbel ma' tilqima ta' referenza li ntweriet li hija effikaċi fl-ispeċi li fuqhom ser jintuża l-prodott
English: 18 October 2019 EMA/559309/2019 EMEA/H/C/004468
Maltese: 18 ta' Ottubru 2019 EMA/559309/2019 EMEA/H/C/004468
English: Further information on the orphan designation can be found on the Agency's website: ema.europa.eu/medicines/human/orphan-designations/eu309622.
Maltese: ema.europa.eu/medicines/human/orphan-designations/eu309622.
English: The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion.
Maltese: Il-kumpanija li applikat għallawtorizzazzjoni, Daiichi Sankyo Europe GmbH, tista' titlob rieżami tal-opinjoni fi żmien 15-il jum mirriċevuta tal-opinjoni.
English: The active substance in Vanflyta, quizartinib, is a ‘receptor tyrosine kinase inhibitor'.
Maltese: Is-sustanza attiva f'Vanflyta, il-kwiżartinib, hija "inibitur tar-riċettur tat-tirożina kinażi".
English: How does Vanflyta work?
Maltese: Kif jaħdem Vanflyta?
English: Vanflyta was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 March 2009 for the treatment of AML.
Maltese: Vanflyta kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-23 ta' Marzu 2009 għall-kura tal-AML.
English: It works by blocking FLT3, a protein involved in cell growth and proliferation.
Maltese: Din taħdem billi timblokka l-FLT3, proteina involuta fit-tkabbir u fil-proliferazzjoni taċ-ċelloli.
English: The Agency issued its opinion on 17 October 2019.
Maltese: L-Aġenzija ħarġet l-opinjoni tagħha fis-17 ta' Ottubru 2019.
English: What did the company present to support its application?
Maltese: X'kienu r-raġunijiet ewlenin għar-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq?
English: Refusal of the marketing authorisation for Vanflyta (quizartinib) EMA/559309/2019
Maltese: EMA/559309/2019
English: Vanflyta was developed as a cancer medicine for the treatment of a type of AML called ‘FLT3-ITD positive' (when the cancer cells have a certain change in the gene for a protein called FLT3).
Maltese: Vanflyta ġie żviluppat bħala mediċina kontra l-kanċer għall-kura ta' tip ta' AML imsejħa "pożittiva għal FLT3-ITD" (meta ċ-ċelloli tal-kanċer ikollhom ċertu bidla fil-ġene għal proteina msejħa FT3).
English: Vanflyta was to be used in adult patients whose disease had come back or did not respond to previous treatments and for continuation of treatment after the patient had undergone a haematopoietic stem cell transplant (HSCT, a transplant of cells that can develop into different types of blood cells).
Maltese: Vanflyta kellu jintuża fuq pazjenti adulti li l-marda tagħhom reġgħet tfaċċat jew ma rrispondietx għal kuri preċedenti u għall-kontinwazzjoni tal-kura wara li l-pazjent ikun għamel trapjant taċ-ċelloli staminali emopojetiċi (HSCT, trapjant ta' ċelloli li jistgħu jiżviluppaw f'tipi ta' ċelloli tad-demm differenti).
English: The European Medicines Agency has recommended the refusal of the marketing authorisation for Vanflyta, a medicine intended for the treatment of adults with acute myeloid leukaemia (AML) (a cancer of the white blood cells).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrakkomandat ir-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq ta' Vanflyta, mediċina maħsuba għall-kura ta' adulti b'lewkimja majelojde akuta (AML) (kanċer taċ-ċelloli bojod tad-demm).
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, speak with your clinical trial doctor.
Maltese: Jekk inti qed tipparteċipa fi prova klinika jew fi programm ta' użu b'kompassjoni u teħtieġ aktar informazzjoni dwar il-kura tiegħek, tkellem mat-tabib tal-prova klinika tiegħek.
English: Vanflyta contains the active substance quizartinib and was to be available as tablets.
Maltese: Vanflyta fih is-sustanza attiva kwiżatinib u kellu jiġi bħala pilloli.
English: By blocking FLT3, quizartinib is expected to stop cancer cells from multiplying and thus slow down the progression of the disease.
Maltese: Billi timblokka l-FLT3, il-kwiżartinib hijaa mistennija li twaqqaf liċ-ċelloli tal-kanċer milli jimmultiplikaw u b'hekk titnaqqas ilprogressjoni tal-marda.
English: Διεύθυνση γραφείου: Γιλτίζ 31 CY-3042 Λεμεσός
Maltese: Γιλτίζ 31 CY-3042 Λεμεσός
English: V.J.Salomone Pharma Limited 79, Simpson Street MT-Marsa HMR 14
Maltese: V.J.Salomone Pharma Limited 79, Simpson Street
English: 53158 CY-3301 Λεμεσός
Maltese: Ταχυδρομική Διεύθυνση: Τ.K. 53158 CY-3301 Λεμεσός
English: Take special care with Clopidogrel Sandoz:
Maltese: Tiħux Clopidogrel Sandoz:
English: The incidence of severe cases was 1.4% for clopidogrel and 1.6% for ASA.
Maltese: L-inċidenza ta' każi severi kienet ta' 1.4 % għal clopidogrel u ta' 1.6 % għal ASA.
English: Clopidogrel Sandoz contains the active ingredient Clopidogrel which belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Clopidogrel Sandoz fih is-sustanza attiva Clopidogrel li tifforma parti minn grupp ta' mediċini msejħa prodotti mediċinali ta' antiplejtlets.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/547/001-007
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦALL-KUMMERĊ EU/1/09/547/001-007
English: The association between CYP2C19 genotype and clopidogrel treatment outcome was evaluated in 2 post hoc clinical trial analyses (substudies of CLARITY [n = 465] and TRITON-TIMI 38 [n = 1,477]) and 5 cohort studies (total n = 6,489).
Maltese: L-assoċjazzjoni bejn il-ġenotip CYP2C19 u r-riżultat tal-kura b'clopidogrel ġie evalwat f'2 post hoc analiżi ta' studji kliniċi (sottostudji ta' CLARITY [n=465] u TRITON-TIMI 38 [n=1,477] u f'sett ta' 5 studji (total n=6,489).
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Maltese: Fl-analiżi ta' lintenzjoni tal-kura, ġew osservati 939 avveniment fil-grupp ta' clopidogrel u 1,020 avveniment b'ASA (tnaqqis tar-riskju relattiv (RRR) ta' 8.7 %, [95 % CI: minn 0.2 għal 16.4]; p = 0.045), li jikkorrispondi, għal kull 1,000 pazjent ttrattati għal sentejn, ma' 10 [CI: minn 0 sa 20] pazjenti oħra li evitaw avveniment iskemiku ġdid.
English: H-1034 Budapest Tel: +36 1 430 2890 info.hungary@sandoz.com
Maltese: Budapest Tel: +36 1 430 2890 info.hungary@sandoz.com
English: Mean inhibition of platelet aggregation (IPA) with 5 μM ADP was diminished by 39% (24 hours) and 21% (Day 5) when clopidogrel and omeprazole were administered together.
Maltese: L-inibizzjoni medja ta' l-aggregazzjoni tal-plejtlets (IPA) flimkien ma' 5 μM ta' ADP naqas bi 39% (24 siegħa) u 21% (Jum 5) meta clopidogrel u omeprazole ngħataw flimkien.
English: In a crossover clinical study, clopidogrel (300-mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as clopidogrel) were administered for 5 days.
Maltese: Fi studju kliniku tat-tip crossover, clopidogrel (300 mg bħala d-doża qawwija inizjali segwita minn 75 mg /kuljum) waħdu u ma' omeprazole (80mg fl-istess ħin bħal clopidogrel) ġew amministrati għal 5 ijiem.
English: Clopidogrel Sandoz 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Clopidogrel Sandoz 75 mg
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Maltese: Emorraġija gastrointestinali, dijarea, uġigħ addominali,
English: Detailed information is available on the European Medicines Agency website: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinstab fuq il-website ta' l-Agenzija Ewropea dwar il-Mediċini: http://www.ema.europa.eu/
English: Extensive metabolism: CYP2C19*1/*1 Intermediate metabolism: CYP2C19*1/*2 or *1/*3
Maltese: Metaboliżmu estensiv: CYP2C19*1/*1 Metaboliżmu intermedju:
English: Österreich Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Tel: +43 (0)53382000
Maltese: Österreich Sandoz GmbH Biochemiestrasse 10 A-6250
English: - cimetidine, medicine to treat upset stomach - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy - ticlopidine, other antiplatelet agent.
Maltese: - cimetidine, mediċina li tittratta taqlib ta' l-istonku, - fluoxetine, fluvoxamine, jew moclobemide, mediċinii li jittrattaw d-dipressjoni, - carbamazepine, jew oxcarbazepine, mediċini li jittrattaw xi tip ta' epilessija, ticlopidine, sustanzi oħra kontra l-plejtlets.
English: signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Take special care with Clopidogrel Sandoz').
Maltese: Madanakollu, jekk id-demm li ħiereġ jinkwetak, għandek tkellem lit-tabib tiegħek minnufih (ara sezzjoni 2 'Oqgħod attent ħafna b'Clopidogrel Sandoz').
English: Clopidogrel Sandoz is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Maltese: Clopidogrel Sandoz jittieħed biex inaqqas ir-riskju li emboli tad-demm (trombi) jifformaw fl-arterji mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li jista' jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: SK-821 04 Bratislava Tel: +421 2 48 200 600
Maltese: Tel: +421 2 48 200 600
English: Children and adolescents Clopidogrel Sandoz is not intended for use in children or adolescents.
Maltese: Tfal u adolexxenti Clopidogrel Sandoz m'għandux jingħata lit-tfal jew lill-adolexxenti.
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Sandoz: if you have a risk of bleeding such as a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body) a recent serious injury a recent surgery (including dental) a planned surgery (including dental) in the next seven days if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
Maltese: • jekk tinsab f'riskju ta' fsada bħal: kundizzjoni medika li tpoġġik f'riskju ta' fsada interna (bħal ulċera fl-istonku) mard fid-demm li jwassal għal fsada interna (dmija f'xi tessuti, organi jew ġogi ta' ġismek); ferita serja riċenti; operazzjoni riċenti (anki tas-snien); operazzjoni li ser issirlek (anki tas-snien) fis-sebat ijiem li ġejjin.
English: Clopidogrel Sandoz 75 mg film-coated tablets Clopidogrel
Maltese: Clopidogrel Sandoz 75 mg pilloli miksija b'rita Clopidogrel
English: What Clopidogrel Sandoz contains The active substance is clopidogrel.
Maltese: Is-sustanza attiva hi clopidogrel.
English: What Clopidogrel Sandoz looks like and contents of the pack
Maltese: Id-Dehra ta' Clopidogrel Sandoz u l-kontenuti tal-pakkett
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE
Maltese: • Għandek ukoll tgħid lit-tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika (magħrufa wkoll bħala Purpura Trombotika Tromboċitopenika jew TTP) li tinkludi deni u tbenġil taħt il-ġilda li jidher bħal tikek ħomor irqaq, flimkien ma' jew mingħajr għeja kbira mhux spjegata, konfużjoni, sfurija tal-ġilda jew ta' l-għajnejn (suffejra) (ara sezzjoni 4 'EFFETTI SEKONDARJI LI JISTA' JKOLLU').
English: If you experience prolonged bleeding when taking Clopidogrel Sandoz.
Maltese: Jekk tbati minn fsada għal perjodu twil waqt li qed tieħu Clopidogrel Sandoz.
English: Thrombocytopenia, leucopenia,
Maltese: Qalba tal-pillola:
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Sandoz 75 mg film-coated tablets Clopidogrel
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel Sandoz 75 mg pilloli miksija b'rita Clopidogrel
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Sandoz 75 mg film-coated tablets
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel Sandoz 75 mg pilloli miksija b'rita
English: Other side effects reported with clopidogrel are: -Common side effects:
Maltese: Effetti oħra li ġew irrappurtati bi clopidogrel huma:
English: EXP
Maltese: Ematoma
English: Ταχυδρομική Διεύθυνση: Τ.K.
Maltese: Διεύθυνση γραφείου:
English: Verovśkova 57
Maltese: GR-175 64
English: • Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg with or without food.
Maltese: • Adulti u anzjani Clopidogrel għandu jingħata darba kuljum bħala doża ta' 75 mg ma' l-ikel jew mingħajru.
English: The MAH shall conduct a non-interventional post-authorisation safety study (PASS) to evaluate the safety of Targocid in adults with Gram-positive infections who are exposed to the higher loading dose of 12mg/kg twice a day (24 mg/kg/day).
Maltese: Il-MAH għandu jwettaq studju mhux ta' intervent dwar is-sikurezza wara l-awtorizzazzjoni (PASS) sabiex jevalwa s-sigurtà ta' Targocid f'adulti b'infezzjonijiet Gram-pożittivi li huma esposti għall-ogħla doża ta' tagħbija ta' 12mg/kg darbtejn kuljum (24 mg/kg/kuljum).
English: The protocols, abstracts and final study reports shall be submitted in the format set out in Annex III of Commission Implementing Regulation (EC) No 520/2012.
Maltese: III tar-Regolament ta' Implimentazzjoni tal-Kummissjoni (UE) Nru 520/2012.
English: Post-authorisation safety study (PASS)
Maltese: L-istudju dwar is-sikurezza wara l-awtorizzazzjoni (PASS)
English: Annex IV Conditions to the marketing authorisation
Maltese: Anness IV Il-kundizzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq
English: Risk management plan The MAH shall submit a RMP within 6 months of the Commission Decision.
Maltese: Il-pjan għall-immaniġġjar tar-riskji Il-MAH għandu jissottometti RMP fi żmien 6 xhur mid-Deċiżjoni tal-Kummissjoni.