FrancophonIA/ELRC3.0 huggingface dataset:
English: GEDEON RICHTER ROMÂNIA S.A. Str. Cuza-Vodă nr.
Maltese: Ir-Rumanija GEDEON RICHTER ROMÂNIA S.A. Str. Cuza-Vodă nr.
English: FIN-02200 ESPOO Finland
Maltese: FIN-02200
English: Stadapharm GmbH Stadastr.
Maltese: Il-Ġermanja Stadapharm GmbH Stadastr.
English: D-22459 Hamburg Germany
Maltese: D-22459 Hamburg
English: Richter Gedeon nyrt.
Maltese: L-Ungerija Richter Gedeon nyrt.
English: 1103, Budapest Hungary
Maltese: 1103, Budapest
English: S.C. TERAPIA S.A. Str. Fabricii nr. 124, Cluj Napoca, România
Maltese: Fabricii nr. 124, Cluj Napoca,
English: Tablets oral use
Maltese: Pilloli
English: 25D83607 Holzkirchen Germany
Maltese: Il-Ġermanja HEXAL AGIndustriestr. 25D83607 Holzkirchen
English: 99-105,Târgu Mureş, România
Maltese: 99-105,Târgu Mureş,
English: Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Maltese: Il-Ġermanja Aliud Pharma GmbH Gottlieb-Daimler-Str.
English: EMA/840902/2011 EMEA/V/C/0002497
Maltese: EMEA/840902/2011 EMEA/V/C/0002497
English: Inflacam (meloxicam)
Maltese: Inflacam (melossikam)
English: Inflacam received a marketing authorisation valid throughout the EU on 9 December 2011.
Maltese: Inflacam ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-9 ta' Diċembru 2011.
English: Inflacam contains the active substance meloxicam and is a generic medicine.
Maltese: Inflacam fih is-sustanza attiva melossikam u huwa mediċina ġenerika.
English: The withdrawal period for meat is five days for the 20 mg/ml solution for injection and three days for the granules and 15 mg/ml oral suspension.
Maltese: Il-perjodu ta' tiżmim għal-laħam huwa ħamest ijiem għas-soluzzjoni għall-injezzjoni ta' 20 mg/ml u tlitt ijiem għall-granuli fil-qratas u għas-sospensjoni orali ta' 15 mg/ml.
English: Further information on Inflacam can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports Information on the reference medicine can also be found on the Agency's website.
Maltese: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports Informazzjoni dwar il-mediċina ta' referenza tinstab ukoll fis-sit elettroniku tal-Aġenzija.
English: In pigs, Inflacam is used to reduce lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move), for the relief of post-operative pain after minor soft tissue surgery such as castration, and for supportive therapy together with appropriate antibiotic therapy in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome).
Maltese: Fil-ħnieżer, Inflacam, jintuża biex titnaqqas iz-zappip u l-infjammazzjoni f'disturbi lokomotorji mhux infettivi (mard li jaffettwa l-ħila taċ-ċaqliq), għat-taffija tal-uġigħ li jinħass wara operazzjonijiet assoċjat ma' interventi kirurġiċi fuq it-tessut artab minuri bħall-kastrazzjoni, u bħala terapija ta' appoġġ flimkien ma' terapija bl-antibijotiċi adatti fil-kura ta' mard li jiżviluppa wara t-tifrigħ (twelid) bħas-settiċemija pwerperali u t-tossjemija (sindromu tal-mastite-metrite-agalassija).
English: How has Inflacam been studied?
Maltese: Kif ġie studjat Inflacam?
English: In cattle, Inflacam is used together with appropriate antibiotic therapy, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways).
Maltese: Fl-ifrat, Inflacam jintuża flimkien ma' terapija antibijotika adatta, biex inaqqas is-sintomi kliniċi talinfezzjoni respiratorja akuta (infjammazzjoni fil-pulmun u fil-passaġġi tal-arja).
English: Inflacam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: Inflacam fih il-melossikam, li tagħmel parti minn klassi ta' mediċini msejħa mediċini antinfjammatorji mhux sterojdi (NSAIDs).
English: What are the benefits and risks of Inflacam?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Inflacam?
English: Inflacam is available as granules, an oral (taken by mouth) suspension , chewable tablets and solution for injection .
Maltese: Inflacam jiġi bħala granuli, bħala sospensjoni orali (meħud oralment), pilloli tal-magħad u soluzzjoni għall-injezzjoni.
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Maltese: Il-melossikam taġixxi billi timblokka enzima msejħa ċiklossiġenażi li hija involuta fil-produzzjoni tal-prostaglandini.
English: Since Inflacam is a generic medicine, studies have been conducted to determine that it is bioequivalent to the reference medicine, Metacam.
Maltese: Billi Inflacam huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jistabbilixxu lbijoekwivalenza tiegħu mal-mediċina ta' referenza, Metacam.
English: How does Inflacam work?
Maltese: Kif jaħdem Inflacam?
English: This means that Inflacam contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Metacam.
Maltese: Dan ifisser li Inflacam fih l-istess sustanza attiva u jaħdem bl-istess mod ta' “mediċina ta' referenza” diġà awtorizzata fl-Unjoni Europea (UE) msejħa Metacam.
English: In cats, Inflacam is used to reduce post-operative pain and inflammation after ovariohysterectomy (spaying operation), orthopaedic and minor soft tissue surgery.
Maltese: Fil-qtates, Inflacam jintuża biex inaqqsilhom l-uġigħ u l-infjammazzjoni wara li tkun saritilhom ovarjoisterektomija (operazzjoni li tneħħi l-ovarji u l-utru), intervent kirurġiku ortopediku u intervent kirurġiku fuq it-tessut artab.
English: It can also be used as supportive therapy in the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.
Maltese: Jista' jintuża wkoll bħala terapija ta' appoġġ fil-kura ta' mastite akuta (infjammazzjoni tal-glandola mammarja), flimkien mal-antibijotiċi.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Maltese: Peress li l-prostaglandini huma sustanzi li jiskattaw linfjamazzjoni, l-uġigħ, it-tnixxija (fluwidu li joħroġ mill-vażi waqt infjamazzjoni) u d-deni, ilmelossikam tnaqqas dawn is-sinjali tal-marda.
English: In dogs, Inflacam is used to reduce post-operative pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery.
Maltese: Fil-klieb, Inflacam jintuża biex inaqqsilhom l-uġigħ u l-infjammazzjoni wara li tkun saritilhom operazzjoni ortopedika b'intervent kirurġiku (eż. operazzjoni fuq ksur) u intervent kirurġiku fuq it tessut artab.
English: The precautions are the same as for the reference medicine since Inflacam is a generic medicine.
Maltese: Il-prekawzjonijiet huma bħal dawk tal-mediċina ta' referenza minħabba li Inflacam huwa mediċina ġenerika.
English: Because Inflacam 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 Inflacam huwa mediċina ġenerika u bijoekwivalenti għall-mediċini ta' referenza, ilbenefiċċji u r-riskji tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: In horses, Inflacam is used to reduce pain associated with colic (abdominal pain) and to lessen inflammation and relieve pain in acute and chronic musculo-skeletal disorders (disorders affecting the muscles and bones).
Maltese: Fiż-żwiemel, Inflacam jintuża għat-taffija tal-uġigħ assoċjat mal-kolika (uġigħ addominali) u għattaffija tal-infjammazzjoni u tal-uġigħ f'disturbi muskoluskeletali (disturbi li jaffettwaw il-muskoli u lgħadam).
English: London, 14 August 2008 EMEA/CHMP/524251/2008
Maltese: Londra, 14 ta' Awwissu 2008 EMEA/CHMP/524260/2008
English: Avelox was initially approved in June 1999.
Maltese: Avelox ġie approvat inizjalment f'Ġunju 1999.
English: Avelox film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Maltese: Avelox pilloli miksijin b'rita fihom 400 mg moxifloxacin bħala hydrochloride.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Avelox and associated names International non-proprietary name (INN): moxifloxacin BACKGROUND INFORMATION *
Maltese: (CHMP) WARA RIFERIMENT SKOND L-ARTIKOLU 6 (12) Avelox u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): moxifloxacin INFORMAZZJONI TA' SFOND *
English: EMA/252150/2014 EMEA/H/C/002621
Maltese: EMEA/H/C/002621
English: Hemangiol is a medicine that contains the active substance propranolol.
Maltese: Hemangiol huwa mediċina li fiha s-sustanza attiva propranolol.
English: The full EPAR and risk management plan summary for Hemangiol 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: Other information about Hemangiol
Maltese: Informazzjoni oħra dwar Hemangiol
English: Hemangiol was investigated in one main study involving 460 children aged from five weeks to five months at the start of treatment and who had proliferative infantile haemangioma that required systemic therapy.
Maltese: Hemangiol ġie investigat fi studju ewlieni wieħed li involva 460 tifel u tifla li għandhom bejn ħames ġimgħat u ħames xhur fil-bidu tal-kura u li kellhom emanġjoma infantili proliferattiva li kienet teħtieġ terapija sistemika.
English: This is a summary of the European public assessment report (EPAR) for Hemangiol.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Hemangiol.
English: The dose is progressively increased to a maintenance dose of 1.5 mg/kg twice a day.
Maltese: Id-doża tiżdied progressivament għal doża ta' manteniment ta' 1.5 mg/kg darbtejn kuljum.
English: Serious side effects observed with Hemangiol include bronchospasm (temporary narrowing of the airways) and low blood pressure.
Maltese: Effetti sekondarji serji osservati b'Hemangiol jinkludu bronkospażmu (tidjiq temporanju tal-passaġġi tan-nifs) u pressjoni tad-demm baxxa.
English: In around 60% (61 out of 101) of children treated with the most effective dose of Hemangiol (3 mg/kg/day for 6 months), haemangiomas disappeared completely or almost completely compared with around 4% (2 out of 55) in children who received placebo.
Maltese: F'madwar 60 % (61 minn 101) tat-tfal ikkurati bid-doża laktar effikaċi ta' Hemangiol (3 mg/kg/kuljum għal 6 xhur), l-emanġjomi sparixxew kompletament jew kważi kompletament meta mqabbel ma' 4 % (2 minn 55) fit-tfal li rċevew plaċebo.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku propranolol
English: Why is Hemangiol approved?
Maltese: Għaliex ġie approvat Hemangiol?
English: The recommended starting dose of Hemangiol is 0.5 mg per kilogram bodyweight (0.5 mg/kg), twice a day (at least 9 hours apart).
Maltese: Id-doża tal-bidu rakkomandata ta' Hemangiol hija 0.5 mg għal kull kilogramma ta' piż tal-ġisem (0.5 mg/kg), darbtejn kuljum (tal-anqas 9 sigħat bejniethom).
English: Hemangiol must not be used in: premature babies who have not reached the corrected age of 5 weeks (the corrected age is the age a premature baby would be if he/she had been born on the due date); breastfed children if the mother is being treated with medicines that must not be used with propranolol; children with asthma or with a history of bronchospasm; children with certain diseases of the heart and blood vessels, such as low blood pressure; and children who tend to have low blood sugar levels.
Maltese: Hemangiol ma għandux jintuża fi: trabi prematuri li ma jkunux laħqu l-età korretta ta' 5 ġimgħat (l-età korretta hija l-età li tarbija prematura kien ikollha li kieku twieldet fid-data mistennija); tfal mredda' jekk l-omm tkun qed tiġi kkurata b'mediċini li ma għandhomx jintużaw ma' propranolol; tfal bl-ażżma jew bi storja ta' bronkospażmu; tfal b'ċertu mard tal-qalb u l-vini u l-arterji tad-demm, bħall-pressjoni tad-demm baxxa; u t-tfal li għandhom tendenza li jkollhom livelli baxxi ta' zokkor fid-demm.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hemangiol on 23 April 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Hemangiol fit-23 ta' April 2014.
English: Although it is not exactly known how Hemangiol works in proliferative infantile haemangioma, it is thought to do so by several mechanisms including narrowing the blood vessels and so decreasing blood supply to the haemangioma, blocking the formation of new blood vessels in the growth, triggering cell death of the abnormal blood vessel cells and blocking the effect of certain proteins (called VEGF and bFGF), which are important for the growth of blood vessels.
Maltese: Għalkemm mhuwiex magħruf eżatt kif jaħdem Hemangiol f'emanġjoma infantili proliferattiva, huwa maħsub li jagħmel dan permezz ta' diversi mekkaniżmi, inkluż billi jdejjaq il-vini u l-arterji tad-demm u b'hekk inaqqas il-provvista tad-demm għall-emanġjoma, jimblokka l-formazzjoni ta' vini u arterji taddemm ġodda fit-tkabbir, jistimula l-mewt taċ-ċelloli tal-vini u l-arterji tad-demm u jimblokka l-effetti ta' ċerti proteini (imsejħa VEGF u bFGF) li huma importanti għat-tkabbir tal-vini u l-arterji tad-demm.
English: What are the risks associated with Hemangiol?
Maltese: X'inhuma r-riskji assoċjati ma' Hemangiol?
English: This summary was last updated in 04-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar 04-2014.
English: Hemangiol at a dose of 3 mg/kg per day (given as two separate doses of 1.5 mg/kg) given for 6 months was shown to be more effective than placebo.
Maltese: Hemangiol f'doża ta' 3 mg/kg kuljum (mogħtija bħala żewġ dożi separati ta' 1.5 mg/kg) għal 6 xhur intwera li kien aktar effikaċi minn plaċebo.
English: It is used to treat children with proliferating infantile haemangioma, which are benign tumours (abnormal non-cancerous growths) of blood vessels.
Maltese: Jintuża biex jikkura tfal b'emanġjoma infantili proliferanti, li huma tumuri beninji (tkabbir mhux kanċeruż anormali) tal-vini u l-arterji taddemm.
English: The most common side effects with Hemangiol (which may affect more than 1 in 10 children) are sleep disorders, respiratory tract infections such as bronchitis (inflammation of the airways in the lungs), diarrhoea and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'Hemangiol (li jistgħu jaffettwaw aktar minn 1 minn kull 10 itfal) huma disturbi fl-irqad, infezzjonijiet fl-apparat respiratorju bħal bronkite (infjammazzjoni tal-passaġġi tan-nifs fil-pulmuni), dijarea u remettar.
English: The active substance in Hemangiol, propranolol, belongs to a group of medicines called beta-blockers, which have been widely used to treat several conditions in adults, including diseases of the heart and high blood pressure.
Maltese: Is-sustanza attiva f'Hemangiol, propranolol, tagħmel parti minn grupp ta' mediċini msejħa imblokkaturi beta, li ntużaw ħafna biex jikkuraw diversi kundizzjonijiet fl-adulti, inkluż mard tal-qalb u pressjoni għolja tad-demm.
English: Hemangiol is used in infants with serious complications, such as painful ulcers, scarring and breathing difficulties, who require systemic therapy (treatment which can have an effect on the whole body).
Maltese: Hemangiol jintuża fi trabi li għandhom kumplikazzjonijiet serji, bħal ulċeri b'uġigħ, ċikatriċi u diffikultajiet fin-nifs, li jeħtieġu terapija sistemika (kura li jista' jkollha effett fuq il-ġisem kollu).
English: The Committee concluded that Hemangiol was an effective treatment for haemangioma.
Maltese: Il-Kumitat ikkonkluda li Hemangiol kien kura effikaċi għal emanġjoma.
English: A risk management plan has been developed to ensure that Hemangiol is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Hemangiol jintuża bl-aktar mod sigur possibbli.
English: Hemangiol propranolol
Maltese: Kif jintuża Hemangiol?
English: Regarding safety, the CHMP considered that the safety profile is acceptable; the risks identified are those already known for propranolol and can be appropriately managed.
Maltese: Fir-rigward tas-Sigurtà, is-CHMP ikkunsidra li l-profil tas-sigurtà huwa aċċettabbli; ir-riskji identifikati huma dawk diġà magħrufa għal propranolol u jistgħu jiġu ġestiti b'mod xieraq.
English: The study compared different doses of propranolol with placebo (a dummy treatment) and the main measure of effectiveness was based on whether the haemangiomas disappeared completely or almost completely after 6 months of treatment.
Maltese: L-istudju qabbel dożi differenti ta' propranolol ma' plaċebo (kura finta) u l-kejl ewlieni tal-effikaċja kien ibbażat fuq jekk l-emanġjomi sparixxewx kompletament jew kważi kompletament wara 6 xhur ta' kura.
English: For the full list of all side effects reported with Hemangiol, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Hemangiol, ara l-fuljett ta' tagħrif.
English: Phenprocoumon is contraindicated during pregnancy (see section 4.3).
Maltese: Phenprocoumon huwa kontraindikat waqt it-tqala (ara sezzjoni 4.3).
English: Adopted at the 9-12 April 2018 PRAC
Maltese: Adottati fil-PRAC ta' bejn id-9 u t-12 ta' April 2018
English: Fertility
Maltese: Ħorriqija
English: Common: pneumonia (including bacterial, viral, and fungal), upper respiratory tract infection/inflammation, herpes virus infection (including cytomegalovirus-CMV), enterocolitis infection, sepsis (including uncommon cases with fatal outcomes)
Maltese: Komuni: pnewmonja (inklużi batterjali, virali u fungali), infezzjoni/infjammazzjoni fl-apparat respiratorju ta' fuq, infezzjoni tal-virus tal-herpes (inklużi cytomegalovirus-CMV), infezzjoni enterocolitis, sepsis (inklużi każijiet mhux komuni b'riżultati fatali)
English: Not known: frequency cannot be estimated from available data
Maltese: Mhux magħrufa: il-frekwenza ma tistax tiġi stmata mill-informazzjoni disponibbli
English: Table 2: Tabulated summary of adverse reactions
Maltese: Tabella 2: Sommarju f'tabella tar-reazzjonijiet avversi
English: In humans phenprocoumon crosses the placental barrier.
Maltese: Fil-bnedmin, phenprocoumon jaqsam il-barriera tal-plaċenta.
English: Frequency not known: pulmonary arterial hypertension
Maltese: Frekwenza mhux magħrufa: pressjoni għolja arterjali pulmonari
English: Amitriptyline - Dry eye (EPITT no 19173)
Maltese: Amitriptyline - Għajnejn xotti (EPITT nru 19173)
English: Dasatinib - Cytomegalovirus (CMV) reactivation (EPITT no
Maltese: Dasatinib - riattivazzjoni tas-Ċitomegalovirus (CMV) (EPITT nru 19111)
English: Lapatinib - Pulmonary hypertension (EPITT no 19089)
Maltese: 3. Lapatinib - Pressjoni għolja arterjali pulmonari (EPITT nru 19089)
English: Phenprocoumon - Risk of birth defects and foetal loss following first trimester exposure as a function of the time of withdrawal (EPITT no 18902)
Maltese: Phenprocoumon - Riskju ta' difetti fit-twelid u telf tal-fetu wara l-esponiment tal-ewwel trimestru bħala funzjoni tażżmien tal-irtirar (EPITT nru 18902)
English: There is also a risk of bleeding in the foetus (foetal hemorrhage).
Maltese: Hemm ukoll riskju ta' fsada fil-fetu (emorraġija fetali).
English: Fertility, pregnancy and lactation
Maltese: Anġjodema, urtikarja
English: If the patient becomes pregnant while taking <…>, the patient should immediately be switched to a safer alternative treatment (e.g. heparin) and close follow-up including level II ultrasound should be recommended.
Maltese: Jekk il-pazjenta tinqabad tqila waqt li tkun qed tieħu <…>, il-pazjenta għandha immedjatament tinqaleb għal kura alternattiva aktar sikura (eż. heparin) u tingħata segwitu mill-qrib inkluż billi jiġi rrakkomandat ultrasound fil-livell II.
English: Vortioxetine - Angioedema and urticaria (EPITT no
Maltese: Vortioxetine - Anġjodema u urtikarja (EPITT nru 19099)
English: Frequency not known: pulmonary arterial hypertension (increased blood pressure in the arteries (blood vessels) of the lungs)
Maltese: Frekwenza mhux magħrufa: pressjoni għolja arterjali pulmonary (żieda fil-pressjoni tad-demm fl-arterji (kanali tad-demm) tal-pulmun)
English: Possible side effects Frequency ‘not known': Dry eyes
Maltese: Effetti sekondarji possibbli Frekwenza “mhux magħrufa”:
English: Undesirable effects Tabulated list of adverse reactions Skin and subcutaneous tissue disorders Frequency ‘not known': Angioedema, urticaria
Maltese: Effetti mhux mixtieqa Taħt is-sistema tal-klassifika “Disturbi fl-għajnejn” Frekwenza “mhux magħrufa”:
English: No information is available regarding the influence of <…> on fertility.
Maltese: Mhija disponibbli l-ebda informazzjoni dwar l-influwenza ta' <…> fuq il-fertilità.
English: No information on effects of <…> on fertility is available.
Maltese: Mhija disponibbli l-ebda informazzjoni dwar l-effetti ta' <…> fuq il-fertilità.
English: Women of childbearing potential planning a pregnancy should be switched to a safer alternative treatment prior to pregnancy.
Maltese: In-nisa li jista' jkollhom it-tfal li qed jippjanaw tqala għandhom jinqalbu għal kura alternattiva aktar sikura qabel it-tqala.
English: In cases of exposure to phenprocoumon during second and third trimester of pregnancy, the foetus is at an increased risk of intrauterine or parturitional (cerebral) hemorrhage due to foetal anticoagulation.
Maltese: F'każijiet ta' esponiment għal phenprocoumon matul it-tieni u t-tielet trimestru tat-tqala, il-fetu jinsab f'riskju akbar ta' emorraġija (ċerebrali) fl-utru jew waqt it-twelid minħabba antikoagulazzjoni tal-fetu.
English: There is epidemiological evidence suggesting that the risk of birth defects and foetal death increases with the increasing duration of exposure to phenprocoumon during the first trimester of pregnancy, with a steep increase of the rate of major birth defects when phenprocoumon treatment is continued beyond the 5th gestational week.
Maltese: Hemm evidenza epidemjoloġika li tissuġġerixxi li r-riskju tad-difetti fittwelid u tal-mewt tal-fewtu jiżdied meta tiżdied id-durata tal-esponiment għal phenprocoumon matul lewwel trimestru tat-tqala, b'żieda qawwija fir-rata ta' difetti kbar fit-twelid meta l-kura b'phenprocoumon titkompla wara l-ħames ġimgħa ta' ġestazzjoni.
English: If you wish to get pregnant or if you already became pregnant while taking this medicine, talk to your doctor immediately as you should be switched to a safer alternative treatment (e.g. heparin) if you are planning a pregnancy or immediately after recognition of pregnancy.
Maltese: Jekk tixtieq li tinqabad tqila jew jekk inti diġà nqbadt tqila waqt li kont qed tieħu din il-mediċina, kellem immedjatament lit-tabib tiegħek peress li inti għandek tinqaleb għal kura alternattiva aktar sikura (eż. heparin), jekk inti qed tippjana li tinqabad tqila jew immedjatament wara li ssir taf li nqbadt tqila.
English: 25, 25, 8 micrograms
Maltese: 25, 25, 8 mikrogrammi
English: Antibody (cut-off)
Maltese: Antikorp (cut-off)
English: • Polio: a viral infection.
Maltese: • Poljo: infezzjoni virali.
English: 0.32 milligrams Al3+
Maltese: 0.32 milligrammi Al3+
English: Haemophilus influenzae type b polysaccharide
Maltese: Haemophilus influenzae tip b polysaccharide
English: See also section 4 Possible side effects.
Maltese: Ara wkoll sezzjoni 4 Effetti sekondarji possibbli.
English: 0.5 milligrams Al3+
Maltese: 0.5 milligrammi Al3+
English: GSK Vaccines GmbH Emil-von-Behring-Str. 76, D-35041 Marburg Germany
Maltese: GSK Vaccines GmbH Emil-von-Behring-Str. 76, D-35041 Marburg
English: 2 Adverse reactions from spontaneous reporting.
Maltese: 2 Reazzjonijiet avversi minn rappurtar spontanju.
English: 32 D-antigen unit
Maltese: 32 Unità ta' D-antiġen
English: Poliovirus (inactivated) type 1, 2, 3
Maltese: Poliovirus (inattivat) tip 1,2,3
English: N=2009 (12 studies)
Maltese: N=2009 (12-il studju)
English: GlaxoSmithKline Biologicals Kft Homoki Nagy István utca 1.
Maltese: Kft Homoki Nagy István utca 1.
English: Rash, Angioedema2
Maltese: Raxx, Anġioedima2
English: Very common Crying abnormal, irritability, restlessness Common
Maltese: Komuni ħafna Biki mhux normali, irritabilità,