FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal effects, including nausea, vomiting and diarrhoea and anorexia may be early symptoms of overdose having occurred.
Maltese: Effetti gastro-intestinali, li jinkludu dardir, rimettar u dijarea u anoreksja jistgħu jkunu sintomi bikrija ta' doża eċċessiva.
English: A possible association between decreased TPMT activity and secondary leukaemias and myelodysplasia has been reported in individuals receiving 6-mercaptopurine in combination with other cytotoxics (see section 4.8).
Maltese: Assoċjazzjoni possibbli bejn attività mnaqqsa ta' TPMT u lewkimji sekondarji u majelodisplasi ġiet irrapportata f'individwi li kienu qegħdin jirċievu 6-mercaptopurine f'kombinazzjoni ma' ċitotossiċi oħra (ara sezzjoni 4.8).
English: Bacterial and viral infections, infections associated with neutropenia
Maltese: Infezzjonijiet batterjali u virali, infezzjonijiet assoċjati ma' newtropenija
English: Patients treated with 6-mercaptopurine alone or in combination with other immunosuppressive agents, including corticosteroids, have shown increased susceptibility to viral, fungal and bacterial infections, including severe or atypical infection, and viral reactivation.
Maltese: Il-pazjenti kkurati b'6-mercaptopurine biss jew flimkien ma' aġenti immunosoppressivi oħra, inkluż kortikosterojdi, urew suxxettibbiltà miżjuda għal infezzjonijiet virali, fungali u batterjali, inkluż infezzjoni severa jew atipika, u riattivazzjoni virali.
English: Inhibition of the anticoagulant effect of warfarin, when given with 6-mercaptopurine, has been reported.
Maltese: Ġiet irrapportata inibizzjoni tal-effett anti-koagulanti ta' warfarin, meta jingħata ma' 6-mercaptopurine.
English: Serologic testing prior to starting treatment should be considered with respect to hepatitis B. Local guidelines may be considered, including prophylactic therapy for cases which have been confirmed positive by serologic testing.
Maltese: Jistgħu jiġu kkunsidrati linji gwida lokali, inkluż terapija profilattika għal każijiet li ġew ikkonfermati pożittivi permezz ta' ttestjar seroloġiku.
English: As this medicine contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Minħabba li din il-mediċina fiha sucrose, il-pazjenti bi problemi ereditarji rari ta' intolleranza għall-fructose, assorbiment ħażin tal-glucose-galactose jew insuffiċjenza ta' sucrase-isomaltase ma għandhomx jieħdu din il-mediċina.
English: Cases of symptomatic hypoglycaemia have been reported in children with ALL receiving 6-mercaptopurine (see section 4.8).
Maltese: Każijiet ta' ipogliċemija sintomatika ġew irrappurtati fi tfal b'ALL li rċevew 6-mercaptopurine (ara sezzjoni 4.8).
English: Your pack of Xaluprine contains a bottle of medicine, a cap, a bottle adaptor and two dosing syringes (a purple 1 ml syringe and a white 5 ml syringe).
Maltese: Il-pakkett tiegħek ta' Xaluprine fih flixkun tal-mediċina, għatu, adapter tal-flixkun u żewġ siringi tad-dożaġġ (siringa vjola ta' 1 ml u siringa bajda ta' 5 ml).
English: Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215) Potassium sorbate (E202) Sodium hydroxide
Maltese: Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215)
English: Hepatosplenic T-cell lymphoma has been reported in patients with inflammatory bowel disease* treated with azathioprine (the prodrug to 6-mercaptopurine) or 6-mercaptopurine, either with or without concomitant treatment with anti-TNF alpha antibody.
Maltese: ikkurati b'azathioprine (il-prodroga għal 6-mercaptopurine) jew b'6-mercaptopurine, jew bi jew mingħajr kura konkomittanti b'antikorp anti-TNF alpha.
English: One ml of suspension contains 20 mg of mercaptopurine monohydrate.
Maltese: Ml wieħed tas-sospensjoni fih 20 mg ta' mercaptopurine bħala monohydrate.
English: 6-mercaptopurine is also subject to S-methylation by the enzyme thiopurine S-methyltransferase (TPMT), yielding methylmercaptopurine, which is inactive.
Maltese: L-ewwel pass huwa kkatalizzat bi hypoxanthine-guanine phosphoribosyl transferase li jipproduċi thioinosine monophosphate (TIMP). 6-mercaptopurine huwa wkoll soġġett għal S-methylation permezz tal-enzima thiopurine S-methyltransferase (TPMT), li tipproduċi methylmercaptopurine, li hija inattiva.
English: Very rare (affects less than 1 in 10,000 people) - a different type of leukaemia to that being treated - ulcers in the intestines
Maltese: Rari ħafna (jaffetwaw inqas minn persuna 1 minn kull 10,000) - lewkimja ta' tip differenti minn dik li qegħda tiġi kkurata
English: NAME OF THE MEDICINAL PRODUCT Xaluprine 20 mg/ml oral suspension
Maltese: Xaluprine 20 mg/ml sospensjoni orali
English: See section 4
Maltese: (ara sezzjoni 4.4).
English: Allopurinol and other xanthine oxidase inhibitors decrease the rate of catabolism of 6-mercaptopurine.
Maltese: Kombinazzjoni ma' inibituri ta' xanthine oxidase Allopurinol u inibituri oħra ta' xanthine oxidase jnaqqsu r-rata ta' kataboliżmu ta' 6-mercaptopurine.
English: Xanthan gum
Maltese: U L-UŻU
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Maltese: - Taħżinx f'temperatura 'l fuq minn 25°C.
English: Patients receiving immunosuppressive therapy, including mercaptopurine, are at an increased risk of developing lymphoproliferative disorders and other malignancies, notably skin cancers (melanoma and non-melanoma), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ.
Maltese: Il-pazjenti li jkunu qegħdin jirċievu terapija immunosuppressiva, inkluż mercaptpurine, huma f'żieda fir-riskju li jiżviluppaw disturbi limfoproliferattivi u tumuri oħrajn, b'mod partikolari kankrijiet talġilda (melanoma u mhux melanoma), sarkomi (ta' Kaposi u mhux ta' Kaposi) u kanċer ċervikali fl-utru in situ.
English: Hepatotoxicity
Maltese: Sodium hydroxide
English: *inflammatory bowel disease (IBD) is an unlicensed indication
Maltese: *F'pazjenti b'mard infjammatorju tal-imsaren (IBD), indikazzjoni mhux liċenzjata.
English: Xaluprine is used for acute lymphoblastic leukaemia (also called acute lymphocytic leukaemia or ALL).
Maltese: Xaluprine jintuża fil-lewkimja limfoblastika akuta (msejħa wkoll lewkimja limfoċitika akuta jew ALL).
English: Animal studies indicate embryotoxic and embryolethal effects (see section 5.3).
Maltese: Studji fuq l-annimali jindikaw effetti embrijotossiċi u embrijoletali (ara sezzjoni 5.3). Tqala
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Maltese: L-avvenimenti li ġejjin ġew identifikati bħala reazzjonijiet avversi.
English: Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised hosts.
Maltese: It-tilqim permezz ta' vaċċin b'organiżmu ħaj għandu l-potenzjal li jikkawża infezzjoni fl-ospiti immunokompromessi.
English: The 6-mecaptopurine oral suspension and tablet are not bioequivalent with respect to peak plasma concentration, and therefore intensified haematological monitoring of the patient is advised on switching formulations (see section 5.2).
Maltese: 6 mecaptopurine mhumiex bijoekwivalenti fir-rigward tal-konċentrazzjoni massima fil-plażma, u għalhekk huwa rrakkomandat monitoraġġ ematoloġiku intensifikat tal-pazjent waqt il-qlib ta' formulazzjonijiet (ara sezzjoni 5.2).
English: Bone marrow suppression; leucopenia and thrombocytopenia
Maltese: Artralġja, raxx fuq il-ġilda, deni minħabba l-mediċina
English: Other medicines and Xaluprine
Maltese: Kif taħżen Xaluprine
English: The suspension is pink to brown in colour.
Maltese: Is-sospensjoni hija ta' kulur roża fil-kannella.
English: Carcinogenicity Given its genotoxic potential, 6-mercaptopurine is potentially carcinogenic.
Maltese: Karċinoġeniċità Minħabba l-potenzjal ġenotossiku tiegħu, 6-mercaptopurine huwa potenzjalment karċinoġeniku.
English: Treatment with 6-mercaptopurine causes bone marrow suppression leading to leucopenia and thrombocytopenia and, less frequently, to anaemia.
Maltese: Kura bi 6-mercaptopurine tikkawża soppressjoni tal-mudullun li twassal għal lewkopenja u tromboċitopenja u, inqas frekwenti, għal anemija.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of suspension contains 20 mg mercaptopurine (as monohydrate).
Maltese: Ml wieħed ta' sospensjoni fih 20 mg mercaptopurine (bħala monohydrate).
English: Xaluprine also contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) which may cause allergic reactions (possibly delayed).
Maltese: Xaluprine fih ukoll sodium methyl parahydroxybenzoate (E219) u sodium ethyl parahydroxybenzoate (E215) li jistgħu jikkawżaw reazzjonijiet allerġiċi (possibbilment ittardjati).
English: Patients with NUDT15 variant
Maltese: Pazjenti b'varjant NUDT15
English: The mean (90% CI) Cmax with the oral suspension was 39% (22% - 58%) higher than the tablet although there was less between-subject variability (%C.V) with the oral suspension (46%) than the tablet (69%).
Maltese: (22% - 58%) ogħla mill-pillola għalkemm kien hemm inqas varjabilità bejn is-suġġetti (%C.
English: Switching between tablet and oral suspension and vice versa A tablet form of 6-mercaptopurine is also available.
Maltese: Qlib bejn pilloli u sospensjoni orali u viċi-versa 6-mercaptopurine huwa wkoll disponibbli f'forma ta' pillola.
English: When administered orally at a dosage of 75 mg/m2 to 7 paediatric patients, the bioavailability averaged 16% of the administered dose, with a range of 5 to 37%.
Maltese: Meta ngħata b'mod orali f'doża ta' 75 mg/m2 lil 7 pazjenti pedjatriċi, il-bijodisponibilità medja kienet ta' 16% tad-doża mogħtija,
English: Genotypic testing of NUDT15 variants may be considered before initiating 6-mercaptopurine therapy.
Maltese: NUDT15 qabel tinbeda terapija b'6-mercaptopurine.
English: Increases in chromosomal aberrations were observed in the peripheral lymphocytes of leukaemic patients, in a renal cell carcinoma patient who received an unstated dose of 6-mercaptopurine and in patients with chronic renal disease treated at doses of 0.4 - 1.0 mg/kg/day.
Maltese: Kienu osservati żidiet fl-aberrazzjonijiet kromosomali fil-limfoċiti periferali ta' pazjenti bil-lewkimja, f'pazjent bil-karċinoma taċ-ċellola renali li rċevew doża mhux indikata ta' 6-mercaptopurine u f'pazjenti bil-mard kroniku renali li rċevew kura b'dożi ta' 0.4 - 1.0 mg/kg/kuljum.
English: Common (affects less than 1 in 10 people) - feeling or being sick (nausea or vomiting) - liver damage - this may show up in blood tests - a drop in red blood cells which may make you tired, weak or breathless (called anaemia) - loss of appetite - diarrhoea - inflammation of the mouth (stomatitis)
Maltese: Komuni (jaffettwaw inqas minn persuna 1 minn kull 10) - tħossok u tkun ma tiflaħx (dardir jew rimettar) - ħsara lill-fwied - dan jista' joħroġ fit-testijiet tad-demm - tnaqqis fiċ-ċelloli tad-demm ħomor li jista' jagħmlek għajjien, dgħajjef jew bla nifs - msejħa anemija - telf ta' aptit
English: Depending on phase of treatment, starting or target doses generally vary between 25-75 mg/m2 body surface area (BSA) per day, but should be lower in patients with reduced or absent Thiopurine Methyl Transferase (TPMT) enzyme activity (see section 4.4).
Maltese: id-dożi tal-bidu jew dawk fil-mira ġeneralment ivarjaw bejn 25-75 mg/m2 skont l-erja tas-superfiċje tal-ġisem (BSA) kuljum, iżda għandhom ikunu aktar baxxi f'pazjenti b'attività mnaqqsa jew nieqsa tal-enzima Thiopurine Methyl Transferase (TPMT) (ara sezzjoni 4.4).
English: Nova Laboratories Limited Martin House Gloucester Crescent Wigston, Leicester LE18 4YL
Maltese: Wigston, Leicester LE18 4YL Ir-Renju Unit
English: olsalazine, mesalazine or sulfazalazine) inhibit the TPMT enzyme, which metabolises 6-mercaptopurine, they should be administered with caution to patients receiving concurrent Xaluprine therapy (see section 4.4).
Maltese: Minħabba li hemm evidenza in vitro li d-derivati ta' aminosalicylate (eż. olsalazine, mesalazine jew sulfazalazine) jinibixxu l-enzima TPMT, li timmetabolizza 6-mercaptopurine, għandhom jingħataw b'kawtela lill-pazjenti li jkunu qegħdin jirċievu terapija konkomittanti b'Xaluprine (ara sezzjoni 4.4).
English: Neoplasms including lymphoproliferative disorders, skin cancers (melanomas and non-melanomas), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ (see section 4.4).
Maltese: Neoplażmi, inkluż id-disturbi limfoproliferattivi, kankrijiet tal-ġilda (melanoma u mhux melanoma), sarkomi (ta'
English: Secondary leukaemia and myelodysplasia
Maltese: Kull min jimmaniġġa
English: When you are treated with Xaluprine the risk of viral, fungal and bacterial infections is increased and the infections may be more serious.
Maltese: Meta tiġi kkurat/a b'Xaluprine, ir-riskju ta' infezzjonijiet virali, fungali u batterjali jiżdied u linfezzjonijiet jistgħu jkunu aktar serji.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml of suspension contains 20 mg mercaptopurine (as monohydrate).
Maltese: Ml wieħed ta' sospensjoni fih 20 mg ta' mercaptopurine (bħala monohydrate)
English: The larger 5 ml syringe (white), marked 1 ml to 5 ml, is for measuring doses of more than 1 ml.
Maltese: Is-siringa l-kbira ta' 5 ml (bajda), immarkata minn 1 ml sa 5 ml, hija biex tkejjel dożi ta' aktar minn
English: There is low entry of 6-mercaptopurine into the cerebrospinal fluid.
Maltese: Hemm dħul baxx ta' 6-mercaptopurine fil-fluwidu ċerebrospinali.
English: A detrimental effect on these activities cannot be predicted from the pharmacology of the active substance.
Maltese: L-effett detrimentali fuq dawn l-attivitajiet ma jistax jiġi mbassar mill-farmakoloġija tas-sustanza attiva.
English: Xaluprine is hepatotoxic and liver function tests should be monitored weekly during treatment.
Maltese: Xaluprine huwa epatotossiku u t-testijiet tal-funzjoni tal-fwied għandhom jiġu mmonitorjati kull ġimgħa matul il-kura.
English: Therefore, when taking Xaluprine, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor - lymphoproliferative disorders o treatment with Xaluprine increases your risk of getting a type of cancer called lymphoproliferative disorder.
Maltese: Għaldaqstant, meta tieħu Xaluprine, evita esponiment eċċessiv għad-dawl tax-xemx, ilbes ilbies protettiv u uża prodotti ta' protezzjoni kontra x-xemx b'fattur ta' protezzjoni għoli - disturbi limfoproliferattivi o il-kura b'Xaluprine żżidlek ir-riskju li jkollok tip ta' kanċer li jissejjaħ disturb limfoproliferattiv.
English: For mercaptopurine there is a lack of modern clinical documentation which can serve as support for accurately determining the frequency of adverse reactions.
Maltese: Fil-każ ta' mercaptopurine hemm nuqqas ta' dokumentazzjoni klinika moderna li tista' sservi bħala appoġġ biex tiddetermina b'mod preċiż il-frekwenza ta' reazzjonijiet avversi.
English: Since there is a potential for reduced elimination of mercaptopurine, consideration should be given to reduced starting doses in patients with impaired hepatic function.
Maltese: Minħabba li hemm il-potenzjal għal eliminazzjoni mnaqqsa ta' mercaptopurine, għandha tingħata kunsiderazzjoni biex id-dożi tal-bidu jitnaqqsu f'pazjenti b'indeboliment tal-funzjoni epatika.
English: May be harmful for people with phenylketonuria.
Maltese: Żomm il-flixkun magħluq sewwa.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: It-tabib tiegħek sejjer jordnalek id-doża korretta għalik.
English: You should use this one if the total amount you have to take is more than 1 ml (each graduation of 0.2 ml contains 4 mg of mercaptopurine).
Maltese: (kull gradwazzjoni ta' 0.2 ml fiha 4 mg ta' mercaptopurine).
English: These patients generally require dose reduction; particularly those being NUDT15 variant homozygotes (see 4.4).
Maltese: Ġeneralment dawn il-pazjenti jkunu jeħtieġu tnaqqis fid-doża; b'mod partikolari dawn li jkunu omozigoti tal-varjant NUDT15 (ara 4.4).
English: 1 ml and 5 ml dosing syringes.
Maltese: Flixkun tal-ħġieġ ta' 100 ml Adaptor tal-flixkun Siringi tad-dożaġġ ta' 1 ml u 5 ml.
English: The risk of overdose is also increased when xanthine oxidase inhibitors is being given concomitantly with 6-mercaptopurine (see section 4.5).
Maltese: Ir-riskju ta' doża eċċessiva tiżdied ukoll meta l-inibituri ta' xanthine oxidase jingħataw b'mod konkomittanti ma' 6-mercaptopurine (ara sezzjoni 4.5).
English: Effects of mercaptopurine on other medicinal products Concomitant administration of yellow fever vaccine is contraindicated, due to the risk of fatal disease in immunocompromised patients (see section 4.3)
Maltese: Effetti ta' mercaptopurine fuq prodotti mediċinali oħra L-għoti konkomittanti tal-vaċċin tad-deni l-isfar huwa kontra-indikat, minħabba r-riskju ta' mard fatali f'pazjenti immunokompromessi (ara sezzjoni 4.3)
English: Remove the bottle cap (figure 2) and push the adaptor firmly into the top of the bottle and leave in place for future doses (figure 3).
Maltese: Neħħi l-għatu tal-flixkun (Figura 2) u mbotta l-adapter sewwa ġol-parti ta' fuq tal-flixkun u ħallih hemm għal dożi futuri (Figura 3).
English: 100 ml glass bottle Bottle adaptor
Maltese: Kif għandek tieħu Xaluprine
English: The administration of 6-mercaptopurine with food may decrease systemic exposure slightly but this is unlikely to be of clinical significance.
Maltese: L-għoti ta' 6-mercaptopurine mal-ikel jista' jnaqqas l-espożizzjoni sistemika bi ftit imma dan mhuwiex probabbli li jkun ta' sinifikat kliniku.
English: Amber type III glass bottle with tamper evident child-resistant closure (HDPE with expanded polyethylene liner) containing 100 ml of oral suspension.
Maltese: Huwa rrakkomandat li jsir monitoraġġ tal-valur tal-INR (Proporzjon Normalizzat Internazzjonali) matul l-għoti konkomittanti ma' anti-koagulanti orali.
English: 32 mg Dispersible Tablet blister (alu/alu)
Maltese: 32 mg Pillola li tinxtered Użu orali folja (alu/alu)
English: MA (EU) number (Invented) name
Maltese: Numru tal-proċedura ta' l-MA (EU)
English: Immediate Packaging
Maltese: Ilpakkett
English: EU/1/09/548/001 EU/1/09/548/002 EU/1/09/548/003 EU/1/09/548/004 EU/1/09/548/005 EU/1/09/548/006 EU/1/09/548/007
Maltese: EU/1/09/548/001 EU/1/09/548/002 EU/1/09/548/003 EU/1/09/548/004
English: -Very rare side effects:
Maltese: - Effetti sekondarji rari:
English: -Uncommon side effects:
Maltese: - Effetti sekondarji komuni:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/548/001 - 007
Maltese: EU/1/09/548/006 EU/1/09/548/007
English: It also contains hydrogenated castor oil.
Maltese: Fih ukoll castor oil idroġenat.
English: In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p=0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR = 23.7%; CI: 8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 18.7 [p=0.258]).
Maltese: F'analiżi tas-sottogrupp permezz ta' kondizzjoni qwalifikanti (infart mijokardijaku, puplesija iskemika, u PAD) il-benefiċċju jidher li kien l-ikbar (b'relevanza statistika ta' p=0.003) f'pazjenti li ddaħħlu minħabba PAD (speċjalment dawk li kellhom ukoll storja medika ta' infart mijokardijaku) (RRR = 23.7 %; CI: minn 8.9 sa 36.2) u inqas (mhux differenti b'mod sinifikanti minn ASA) f'pazjenti b'puplesija (RRR = 7.3 %; CI: minn -5.7 sa 18.7 [p=0.258]).
English: Clopidogrel Acino Pharma GmbH contains the active ingredient Clopidogrel which belongs to a group of medicines called antiplatelet medicinal products.
Maltese: GmbH fih is-sustanza attiva Clopidogrel li tifforma parti minn grupp ta' mediċini msejħa prodotti mediċinali ta' antiplejtlets.
English: Excipients: each film-coated tablet contains 3.80 mg of hydrogenated castor oil.
Maltese: Sustanzi mhux attivi: kull pillola miksija b'rita fiha 3.80 mg ta' castor oil idroġenat.
English: - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy - ticlopidine, other antiplatelet agent.
Maltese: - 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: You should specifically tell your doctor if you take - oral anticoagulants, medicines used to reduce blood clotting, - a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints - heparin or any other injectable medicine used to reduce blood clotting - omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections
Maltese: Għandek speċifikament tgħid lit-tabib tiegħek jekk qiegħed tieħu - sustanzi kontra l-koagulazzjoni tad-demm li jittieħdu mill-ħalq, mediċini li jraqqu d-demm, - mediċina li hija anti-infjammatorju li mhux sterojde, normalment użat biex jiġi ittrattat l-uġigħ u/jew kundizzjonijiet infjammatorji tal- muskoli jew tal-ġogi, - heparin jew xi mediċina oħra li tinjettaużata biex traqqaq id-demm, - omeprazole, esomeprazole jew cimetidine, mediċini għat-taqlib tal-istonku - fluconazole, voriconazole, ciprofloxacin, jew chloramphenicol, mediċini li jittrattaw infezzjonijiet
English: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste.
Maltese: - Effetti sekondarji rari ħafna: suffejra; uġigħ addominali qawwi flimkien ma' jew mingħajr uġigħ fid-dahar; deni, diffikultajiet fin-nifs kultant assoċjati mas-sogħla; reazzjonijiet allerġiċi ġeneralizzati; nefħa fil-ħalq; infafet fil-ġilda; reazzjoni allerġika fil-ġilda; infjammazzjoni tal-ħalq (stomatite); tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ fil-ġogi; uġigħ muskolari; tibdiliet fil-mod ta'
English: The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparin are co-administered with ASA (see section 4.8)
Maltese: L-inċidenza tad-dmija klinikament sinifikanti kienet simili għal dik osservata meta sustanzi trombolitiċi u heparin jingħataw flimkien ma' ASA (ara sezzjoni 4.8).
English: Batch
Maltese: GmbH.
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 Acino Pharma GmbH').
Maltese: Madanakollu, jekk id-demm li ħiereġ jinkwetak, għandek tkellem lit-tabib tiegħek minnufih (ara sezzjoni 2 'Oqgħod attent ħafna b'Clopidogrel Acino Pharma GmbH').
English: Clopidogrel Acino Pharma GmbH 75 mg film-coated tablets Clopidogrel
Maltese: X'INHU CLOPIDOGREL ACINO PHARMA GMBH U GĦALXIEX JINTUŻA
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Acino Pharma GmbH: 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 if you have kidney or liver disease
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.