FrancophonIA/ELRC3.0 huggingface dataset:
English: The application was at day 177 when the company withdrew.
Maltese: L-applikazzjoni kienet waslet f'jum 177 meta l-kumpanija rtiratha.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu308594.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/medicines/human/orphan-designations/eu308594.
English: This overview was last updated in 10-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'10-2018.
English: Further information on Strensiq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Strensiq
Maltese: Aktar informazzjoni dwar Strensiq tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/Strensiq
English: X-rays of children given Strensiq were also compared with similar x-rays available from 16 children who had not received Strensiq (‘historical controls').
Maltese: L-x-rays ta' tfal li ngħataw Strensiq tqabblu wkoll ma' x-rays simili disponibbli minn 16-il tifel u tifla li ma rċevewx Strensiq (“kontrolli storiċi”).
English: Strensiq contains the active substance asfotase alfa.
Maltese: Strensiq fih is-sustanza attiva asfotażi alfa.
English: The most common side effects with Strensiq (which may affect more than 1 in 10 people) are headache, erythema (reddening of the skin), pain in arms and legs, fever, irritability, injection site reactions (such as pain, rash and itching) and contusion (bruising).
Maltese: L-effetti sekondarji l-aktar komuni bi Strensiq (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma wġigħ ta' ras, eritema (ħmura tal-ġilda), uġigħ fl-idejn u saqajn, deni, irritabbiltà, reazzjonijiet fis-sit tal-injezzjoni (bħal uġigħ, raxx u ħakk) u kontużjoni (tbenġil).
English: Hypophosphatasia is rare, and Strensiq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 3 December 2008.
Maltese: Ipofosfatażija hija rari, u Strensiq ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-3 ta' Diċembru 2008.
English: Patients were given either 2 mg/kg or 3 mg/kg Strensiq three times a week for 24 weeks.
Maltese: Il-pazjenti ngħataw jew 2 mg/kg jew 3 mg/kg ta' Strensiq tliet darbiet fil-ġimgħa għal 24 ġimgħa.
English: Strensiq has been studied in one main study in 13 children between 6 and 12 years of age.
Maltese: Strensiq ġie studjat fi studju ewlieni wieħed fuq 13-il tifel u tifla li għandhom bejn 6 snin u 12-il sena.
English: Strensiq received a marketing authorisation valid throughout the EU on 28 August 2015.
Maltese: Strensiq irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fit-28 ta' Awwissu 2015.
English: Asfotase alfa, the active substance in Strensiq, is a version of the human ALP enzyme and serves as a replacement, thereby increasing levels of working ALP.
Maltese: L-asfotażi alfa, is-sustanza attiva fi Strensiq, hija verżjoni tal-enzima ALP talbniedem u sservi bħala sostituzzjoni, u b'hekk iżżid il-livelli ta' ALP li taħdem.
English: Other information about Strensiq
Maltese: Informazzjoni oħra dwar Strensiq
English: What information is still awaited for Strensiq?
Maltese: Liema informazzjoni għadha mistennija għal Strensiq?
English: Additional data from an extension of this study in children aged 13 to 18 years confirmed the initial results.
Maltese: Data addizzjonali minn estensjoni ta' dan l-istudju fi tfal li kellhom bejn 13 u 18-il sena kkonfermat ir-riżultati inizjali.
English: What are the risks associated with Strensiq?
Maltese: X'inhuma r-riskji assoċjati ma' Strensiq?
English: The enzyme ‘tissue non-specific alkaline phosphatase' (ALP) plays a key role in creating and maintaining healthy bones, and managing calcium and phosphate in the body.
Maltese: L-enzima “fosfatażi alkalina mhux speċifika tat-tessut” (tissue non-specific alkaline phosphatase - ALP) għandha rwol ewlieni fil-ħolqien u ż-żamma ta' għadam b'saħħtu, u fl-immaniġġjar tal-kalċju u l-fosfat fil-ġisem Pazjenti b'ipofosfatażija ma jistgħux jipproduċu biżżejjed ALP li taħdem, u dan iwassal għal għadam dgħajjef.
English: It is given by injection under the skin either six times a week (in a dose of 1 mg per kilogram bodyweight) or three times a week (in a dose of 2 mg/kg).
Maltese: Jingħata b'injezzjoni taħt il-ġilda jew sitt darbiet filġimgħa (f'doża ta' 1 mg kull kilogramma tal-piż tal-ġisem) jew tliet darbiet fil-ġimgħa (f'doża ta' 2 mg/kg).
English: Some of the studies also looked at the dose of 1 mg/kg Strensiq given six times a week.
Maltese: Uħud mill-istudji eżaminaw ukoll id-doża ta' 1 mg/kg ta' Strensiq mogħtija sitt darbiet fil-ġimgħa.
English: As for all medicines, data on the use of Strensiq is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Strensiq hija ssorveljata kontinwament.
English: For the full list of side effects and restrictions with Strensiq, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u rrestrizzjonijiet bi Strensiq, ara l-fuljett ta' tagħrif.
English: The company that markets Strensiq will provide patients and carers with educational materials to ensure that the medicine is used correctly and to minimise the risk of medication errors.
Maltese: Il-kumpanija li tqiegħed Strensiq fis-suq se tipprovdi materjal edukattiv lill-pazjenti u lill-persuni li jieħdu ħsiebhom biex jiġi żgurat li l-mediċina tintuża b'mod tajjeb u biex jiġi minimizzat ir-riskju ta' żbalji fil-medikazzjoni.
English: Given that hypophosphatasia is an extremely rare disease, data in this population will likely remain limited.
Maltese: Billi l-ipofosfatażija hija marda rari ħafna, id-data f'din il-popolazzjoni x'aktarx li ser tibqa' limitata.
English: Strensiq (asfotase alfa)
Maltese: Kif jaħdem Strensiq?
English: Hypophosphatasia is a rare inherited disease of the bones which can lead to early loss of teeth, malformed bones, frequent bone fractures, and difficulty breathing.
Maltese: Ipofosfatażija hija marda rari ereditarja fl-għadam li tista' twassal għal telf bikri ta' snien, malformazzjoni fl-għadam, ksur frekwenti fl-għadam, u diffikultà fit-teħid tan-nifs.
English: The medicine is available as a solution for injection.
Maltese: Il-mediċina tiġi bħala soluzzjoni għall-injezzjoni.
English: Side effects reported with Strensiq are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Strensiq huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: In the historical controls, most children did not experience similar improvements in their joints or gain in height over a comparable period of time.
Maltese: Fil-kontrolli storiċi, ħafna mit-tfal ma esperjenzawx titjib simili fil-ġogi tagħhom jew żieda fit-tul fuq perjodu ta' żmien komparabbli.
English: Since Strensiq has been authorised under exceptional circumstances, the company that markets Strensiq will set up a registry of patients with hypophosphatasia to collect information on the disease and on the long-term safety and effectiveness of Strensiq.
Maltese: Kull sena, l-Aġenzija ser tirrevedi kull informazzjoni ġdida li ssir disponibbli u din il-ħarsa ġenerali ser tiġi aġġornata kif meħtieġ.
English: ATC code: B01A C
Maltese: B01A C
English: 20 tablets 28 tablets 30 tablets 50 tablets 56 tablets 100 tablets 112 tablets 168 tablets
Maltese: 20 pillola 28 pillola 30 pillola 50 pillola 56 pillola 100 pillola 112-il pillola 168 pillola
English: 3 years.
Maltese: 5 sigħat.
English: • Diuretics (e.g., hydrochlorothiazide, furosemide)
Maltese: • Dijuretiċi (eż, hydrochlorothiazide, furosemide)
English: Oral Anticoagulants like warfarin
Maltese: Antikoagulanti orali bħal warfarin
English: Cilostazol is 95-98% protein bound, predominantly to albumin.
Maltese: 95-98% ta' cilostazol jintrabat mal-proteina, prinċipalment mal-albumina.
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara s-sezzjoni 6.1.
English: Refer to sections 4.3 and 4.5.
Maltese: Irreferi għal sezzjonijiet 4.3 u 4.5.
English: The active substance is cilostazol.
Maltese: • Is-sustanza attiva hi cilostazol.
English: Palpitation, tachycardia, angina pectoris, arrhythmia, ventricular extrasystoles
Maltese: Palpitazzjoni, takikardja, angina pectoris, arritmija, ekstrasistoles ventrikulari
English: Oedema (peripheral, face), anorexia
Maltese: Edema (periferika, wiċċ), anoreksja
English: Hepatitis, hepatic function abnormal, jaundice
Maltese: Epatite, funzjoni epatika abnormali,
English: (≥1/10,000 to <1/1000)
Maltese: (≥1/100 sa <1/10) Mhux komuni (≥1/1,000 sa <1/100) Rari
English: • ACE inhibitors (e.g., captopril, lisinopril)
Maltese: • inibituri ta'ACE (eż., captopril, lisinopril)
English: • calcium channel blockers (e.g., verapamil, amlodipine)
Maltese: • imblokkaturi tal-kanali tal-kalċju (eż., verapamil, amlodipine)
English: • angiotensin II receptor blockers (e.g., valsartan, candesartan)
Maltese: • imblokkaturi tar-riċetturi ta' angiotensin II (eż., valsartan, candesartan)
English: • beta blockers (e.g., labetalol, carvedilol);
Maltese: • imblokkaturi tar-riċetturi beta (eż., labetalol, carvedilol);
English: With respect to mortality, the observed 36-month Kaplan-Meier event rate for deaths on study drug with a median time on study drug of 18 months was 5.6% (95%CI of 2.8 to 8.4%) on cilostazol and 6.8% (95% CI of 1.9 to 11.5%) on placebo.
Maltese: F'36 xahar fir-rigward ta' mortalità, ilkażijiet ta' Kaplan-Meier osservati sal-mewt fuq il-mediċina tal-istudju bi żmien medjan ta' 18-il xahar kienet ta' 5.6% (95% CI ta' 2.8 għal 8.4%) fuq cilostazol u 6.8% (95 CI ta' 1.9% għal 11.5%) fuq plaċebo.
English: Maize starch, microcrystalline cellulose, carmellose calcium, hypromellose and magnesium stearate.
Maltese: Lamtu tal-qamħirrum, microcrystalline cellulose, carmellose calcium, hypromellose u magnesium stearate.
English: CONTENTS OF THE PACK AND OTHER INFORMATION
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Myocardial infarction, atrial fibrillation, congestive heart failure, supraventricular tachycardia, ventricular tachycardia, syncope
Maltese: Infart mijokardijaku, fibrillazzjoni atrijali, falliment tal-qalb konġestiva, takikardja supraventrikulari, takikardja ventrikulari, sinkope
English: Cartons containing 14, 20, 28, 30, 50, 56, 98, 100, 112 and 168 tablets as well as hospital packs with 70 (5x14) tablets packed in PVC/Aluminium blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kaxxi tal-kartun li fihom 14, 20, 28, 30, 50, 56, 98 100, 112 u 168 pillola kif ukoll pakketti tal-isptar b'70 (5x14) pillola ppakkjati f' folji tal-PVC/Aluminju.
English: The effect of CYP3A4 and CYP2C19 inducers (such as carbamazepine, phenytoin, rifampicin and St. John's wort) on cilostazol pharmacokinetics has not been evaluated.
Maltese: L-effett tal-indutturi CYP3A4 u CYP2C19 (bħal carbamazepine, phenytoin, rifampicin u St John's wort) fuq il-farmakokinetika ta' cilostazol ma ġietx evalwata.
English: Metabolism and nutrition disorders
Maltese: Disturbi tal-metaboliżmu u n-nutrizzjoni
English: Your medicine is supplied in packs of 14, 20, 28, 30, 50, 56, 98, 100, 112 or 168 tablets or hospital packs with 70 (5x14) tablets.
Maltese: Il-mediċina tiegħek hja fornuta f'pakketti ta' 14, 20, 28, 30, 50, 56, 98, 100 pillola, 112-il pillola jew 168 pillola jew pakketti għall-isptar b'70 (5x14) pillola.
English: There are two major metabolites, a dehydro-cilostazol and a 4'-trans-hydroxy cilostazol, both of which have similar apparent half-lives.
Maltese: Hemm żewġ metaboliti ewlenin, dehydro-cilostazol u 4'-trans-hydroxy cilostazol, it-tnejn li huma għandhom halflives apparentament simili.
English: Myalgia
Maltese: Mijalgija
English: Administration of a single dose of 100 mg cilostazol with 240 ml grapefruit juice (an inhibitor of intestinal CYP3A4) did not have a notable effect on the pharmacokinetics of cilostazol.
Maltese: L-għoti ta' doża waħda ta' 100 mg cilostazol ma' 240 ml meraq tal-grejpfrut (inibitur ta' CYP3A4 intestinali) ma kellux effett notevoli fuq il-farmakokinetika ta' cilostazol.
English: The dehydro metabolite and 4'-transhydroxy metabolite are 97.4% and 66% protein bound respectively.
Maltese: 97.4% u 66% talmetaboliti dehydro u 4'-trans-hydroxy jaqbdu mal-proteini rispettivament.
English: There is no evidence that cilostazol induces hepatic microsomal enzymes.
Maltese: M'hemm l-ebda evidenza li cilostazol jinduċi enzimi mikrosomali tal-fwied.
English: Very common Diarrhoea, abnormal faeces Common
Maltese: Komuni ħafna Dijarea, ippurgar abnormali faeces Komuni
English: The primary route of elimination is urinary (74%) with the remainder excreted in the faeces.
Maltese: Ir-rotta ewlenija ta' eliminazzjoni tkun permezz tal-awrina (74%) u l-kumplament jiġi eliminat mal-ippurgar.
English: Hyperglycaemia, Diabetes mellitus
Maltese: Ipergliċemija, Dijabete mellitus
English: Bleeding tendency, thrombocytopenia, granulocytopenia, agranulocytosis, leukopenia, pancytopenia, aplastic anaemia
Maltese: Mhux magħruf Tendenza ta' fsada, tromboċitopenija, granuloċitopenija, agranuloċitosi, lewkopenija, panċitopenija, anemija aplastika
English: Cilostazol is a PDE III inhibitor with antiplatelet activity.
Maltese: Cilostazol huwa impeditur ta' PDE III b'attività kontra l-plejtlits.
English: Therefore, drugs inhibiting CYP3A4 (e.g., some macrolides, azole antifungals, protease inhibitors) or CYP2C19 (like proton pump inhibitors, PPIs) increase the total pharmacological activity and could have the potential to enhance the undesirable effects of cilostazol.
Maltese: (eż., xi makrolidi, azole antifungali, inibituri tal-protease) jew CYP2C19 (bħal inibituri tal-proton pump, PPIs) iżidu l-attività farmakoloġika totali u jista' jkollhom il-potenzjal li jħarrxu l-effetti mhux mixtieqa ta' cilostazol.
English: Patients with a history of severe tachyarrhythmia Patients treated concomitantly with two or more additional antiplatelet or anticoagulant agents (e.g. acetylsalicylic acid, clopidogrel, heparin, warfarin, acenocoumarol, dabigatran, rivaroxaban or apixaban)
Maltese: • Pazjenti kkurati fl-istess waqt b'żewġ sustanzi oħra jew aktar kontra l-plejtlits jew kontra t-tagħqid tad-demm (eż. acetylsalicylic acid, clopidogrel, heparin, warfarin, acenocoumarol, dabigatran, rivaroxaban jew apixaban)
English: Plasma concentrations (as measured by AUC) of the dehydro and 4`-trans-hydroxy metabolites are ~41% and ~12% of cilostazol concentrations.
Maltese: Il-konċentrazzjonijiet fil-plażma (kif imkejjel mill-AUC) tal-metaboliti dehydro u 4`-trans-hydroxy huma ~ 41% u ~ 12% tal-konċentrazzjonijiet ta' cilostazol.
English: Haematuria, pollakiuria
Maltese: Mhux magħruf Ematuria, pollakijuria
English: The dehydro metabolite is 4-7 times as active a platelet antiaggregant as the parent compound and the 4'-trans-hydroxy metabolite is one fifth as active.
Maltese: Il-metabolit dehydro huwa 4-7 darbiet attiv iżjed bħala antiaggregant tal-plejtlits mill-kompost ġenitur u l-metabolit 4'-trans-hydroxy huwa attiv daqs wieħed f'ħamsa.
English: In clinical trials, smoking (which induces CYP1A2) decreased cilostazol plasma concentrations by 18%.
Maltese: Fi provi kliniċi, it-tipjip (li jinduċi CYP1A2) naqqas il-konċentrazzjonijiet fil-plażma ta' cilostazol bi 18%.
English: Anxiety Nervous system disorders Very common Headache Common
Maltese: Ansjetà Disturbi fis-sistema nervuża Komuni ħafna Uġigħ ta' ras Komuni
English: St. John's wort (a herbal remedy)
Maltese: John's wort (rimedju tal-ħxejjex)
English: Interstitial pneumonia
Maltese: Disturbi psikjatriċi
English: Eczema, skin eruptions, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Maltese: Raxx, ħakk Mhux magħruf Ekżema, infafet fuq il-ġilda, Is-sindromu ta' Stevens-Johnson, nekrolisi epidermali tossika, urtikarja
English: Reduction of the dose to 50 mg twice daily is recommended in patients receiving medicines that strongly inhibit CYP3A4, for example some macrolides, azole antifungals, protease inhibitors, or medicines that strongly inhibit CYP2C19, for example omeprazole (see sections 4.4 and 4.5).
Maltese: Tnaqqis tad-doża għal 50 mg darbtejn kuljum huwa rrakkomandat f'pazjenti li qed jirċievu mediċini li jinibixxu b'mod qawwi lil CYP3A4, eżempju xi macrolides, mediċini kontra lmoffa tal-klassi azole, inibituri tal-protease, jew mediċini li jinibixxu b'mod qawwi lil CYP2C19, eżempju omeprazole (ara sezzjonijiet 4.4 u 4.5).
English: increases in mean ACD ranged from 60.4 - 129.1 metres, whilst mean ICD increases ranged from 47.3 - 93.6 metres.
Maltese: Wara 24 ġimgħa trattament, cilostazol 100 mg b.i.d iż-żieda fil-medja ta' ACD kien ivarja minn 60.4-129.1 metru, waqt li żidiet fil-medja tal-ICD kien ivarja minn 47.
English: Cilostazol has been shown to increase the AUC of lovastatin (sensitive substrate for CYP3A4) and its hydroxy acid by 70%.
Maltese: Cilostazol ġie muri li jżid l-AUC ta' lovastatin (substrat sensittiv għal CYP3A4) u l-metabolit ffurmat minnhu, -hydroxy acid b'70%.
English: <Cilostazol-containing medicinal product> 50 mg <Cilostazol-containing medicinal product> 100 mg [To be completed nationally]
Maltese: < Cilostazol-containing medicinal product > 50 mg tablets
English: The elderly
Maltese: TA' EĊĊIPJENTI
English: Cilostazol is extensively metabolised by CYP enzymes, particularly CYP3A4 and CYP2C19 and to a lesser extent CYP1A2.
Maltese: Cilostazol jiġi metabolizzat b'mod estensiv minn enzimi ta' CYP, b'mod partikolari CYP3A4 u CYP2C19 u b'mod inqas b'CYP1A2.
English: Caution is advised in case of co-administration with statins metabolised by CYP3A4, for example simvastatin, atorvastatin and lovastatin.
Maltese: Il-kawtela hija rakkomandata fil-każ tal-għoti konġunt ma' statins metabolizzati minn CYP3A4, eżempju simvastatin, atorvastatin u lovastatin.
English: Cilostazol is eliminated predominantly by metabolism and subsequent urinary excretion of metabolites.
Maltese: Cilostazol jiġi eliminat prinċipalment bil-metaboliżmu u sussegwentement bl-eliminazzjoni awrinali ta' metaboliti.
English: Administration of cilostazol with omeprazole (an inhibitor of CYP2C19) increased the AUC of cilostazol by 22%, accompanied by a 68% increase in the AUC of the dehydro metabolite and a decrease of 36% in the AUC of the 4`-trans hydroxy metabolite.
Maltese: L-għoti ta' cilostazol ma' omeprazole (inibitur ta' CYP2C19) żied l-AUC ta cilostazol b'22%, flimkien ma' żieda ta' 68% fl-AUC tal-metabolit dehydro u tnaqqis ta' 36% fl-AUC talmetabolit 4`-trans hydroxy.
English: Based on AUC, the overall pharmacological activity of cilostazol increases 34% when co-administered with erythromycin.
Maltese: Ibbażat fuq l-AUC, l-attività farmakoloġika globali ta' cilostazol tiżdied b'34% meta jingħata flimkien ma' erythromycin.
English: The 4`-trans-hydroxy metabolite, with potency one-fifth that of cilostazol, appears to be formed primarily via CYP2C19.
Maltese: Il-metabolit 4`-trans-hydroxy, b'qawwa ta' wieħed minn ħamsa ta' cilostazol, jidher li jiġi ffurmat primarjament permezz ta' CYP2C19.
English: No unusual neoplastic outcomes were observed in two-year carcinogenicity studies in rats at oral (dietary) doses up to 500 mg/kg/day, and in mice at doses up to 1000 mg/kg/day.
Maltese: Ma ġie osservat ebda eżitu neoplastiku mhux tas-soltu fi studji karċinoġeniċi ta' sentejn fuq il-firien f'dożi orali (djetetiku) sa 500 mg/kg/jum, u fil-ġrieden f'dożi sa 1000 mg/kg/jum.
English: Following multiple doses of cilostazol 100 mg twice daily in patients with peripheral vascular disease, steady state is achieved within 4 days.
Maltese: Wara dożi multipli ta' cilostazol 100 mg darbtejn kuljum f'pazjenti b'mard vaskulari periferiku, stat stabbli inkiseb fi żmien 4 ijiem.
English: Eye haemorrhage, epistaxis, gastrointestinal haemorrhage, haemorrhage unspecified, orthostatic hypotension
Maltese: Emorraġija tal-għajnejn, epistassi, emorraġija gastrointestinali, emorraġija mhix speċifika, ipotensjoni ortostatika
English: Based on AUC, the overall pharmacological activity of cilostazol increases 35% when co-administered with ketoconazole.
Maltese: Ibbażat fuq l-AUC, l-attività farmakoloġika globali ta' cilostazol tiżdied b'35% meta jingħata flimkien ma' ketokonazole.
English: Hot flushes, hypertension, hypotension, cerebral haemorrhage, pulmonary haemorrhage, muscle haemorrhage, respiratory tract haemorrhage, subcutaneous haemorrhage
Maltese: Mhux magħruf Fwawar, pressjoni għolja, pressjoni baxxa, emorraġija ċerebrali, emorraġija pulmonari, emorraġija muskolari, emorraġija fl-apparat respiratorju, emorraġija taħt il-ġilda
English: Based on these data, the recommended dose of cilostazol is 50 mg bid in the presence of ketoconazole and similar agents (e.g., itraconazole).
Maltese: Ibbażat fuq din id-dejta, id-doża rrakkomandata ta' cilostazol hija ta' 50 mg bid fil-preżenza ta' ketoconazole u sustanzi simili (eż. itraconazole).
English: There have been rare or very rare reports of haematological abnormalities including thrombocytopenia, leucopenia, agranulocytosis, pancytopenia and aplastic anaemia (see section 4.8).
Maltese: Kien hemm rapporti rari jew rari ħafna ta' anormalitajiet ematoloġiċi li jinkludu tromboċitopenija, lewkopenija, agranuloċitosi, panċitopenija u anemija aplastika (ara sezzjoni 4.8).
English: Cytochrome P-450 enzyme substrates
Maltese: Sottostrati tal-enżima cytochrome P-450
English: Administration of cilostazol with erythromycin (an inhibitor of CYP3A4) resulted in an increase in the AUC of cilostazol by 72%, accompanied by a 6% increase in AUC of the dehydro metabolite and a 119% increase in AUC of the 4`-trans-hydroxy metabolite.
Maltese: L-għoti ta' cilostazol ma' erythromycin (inibitur ta' CYP3A4) irriżulta f'żieda fl-AUC ta' cilostazol b'72%, flimkien ma' żieda ta' 6% fl-AUC tal-metabolit dehydro u żieda ta' 119% fl-AUC tal-metabolit 4'-trans-hydroxy.
English: Approximately 30% of the dose is excreted in the urine as the 4'-trans-hydroxy metabolite.
Maltese: Madwar 30% tad-doża hija eliminata fl-awrina bħala l-metabolit 4'-trans-hydroxy.
English: At lower dose levels, retardations of ossification were observed.
Maltese: F'livelli ta' dożi aktar baxxi, ġie osservat dewmien tal-ossifikazzjoni.
English: Pyrexia, pain
Maltese: FULJETT TA' TAGĦRIF
English: <Cilostazol-containing medicinal product> belongs to a group of medicines called phosphodiesterase type 3 inhibitors.
Maltese: <Prodott mediċinali li fih cilostazol> jappartjeni għal grupp ta' mediċini msejħa inibituri ta' phosphodiesterase tip 3.
English: Cytochrome P-450 enzyme inducers
Maltese: Indutturi enżimatiċi ta' cytochrome P-450
English: The frequencies of reactions observed in the post-marketing period are considered unknown (cannot be estimated from the available data).
Maltese: Il-frekwenzi ta' reazzjonijiet osservati fil-perjodu ta' wara t-tqegħid fis-suq huma meqjusa bħala mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: • anticoagulant medicines (e.g. warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparins).
Maltese: • mediċini kontra t-tagħqid tad-demm (eż. warfarin dabigatran, rivaroxaban, apixaban jew heparins ta' piż molekolari baxx).
English: The medicine must not be administered to patients with a creatinine clearance <25ml/min (see section 4.3).
Maltese: Il-mediċina m'għandhiex tingħata lil pazjenti bi tneħħija tal-kreatinina <25 ml/min (ara sezzjoni 4.3).
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitor excl. heparin.
Maltese: Sustanzi antitrombotiċi, impeditur tal-aggregazzjoni ta' plejtlits li jeskludi l-eparina.
English: Cytochrome P-450 (CYP) enzyme inhibitors
Maltese: Enżimi impedituri ta' cytochrome P-450 (CYP)
English: White, round, flat faced tablets debossed with “OG31” on one side.
Maltese: Pilloli bojod, tondi b'uċuħ ċatti li fuqhom hemm imnaqqqx “OG31” fuq naħa waħda.