FrancophonIA/ELRC3.0 huggingface dataset:
English: O-glucuronides of both topotecan and N-desmethyl topotecan have been identified in the urine.
Maltese: L- O-glucuronide ta' topotecan u lO-glucuronide ta' N-desmethyl topotecan ġew identifikati fl-awrina.
English: Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Maltese: Monoterapija b'topotecan u topotecan flimkien ma' cisplatin huma assoċjati b'mod komuni ma' tromboċitopenja klinikamnet rilevanti.
English: 9/l, the platelet count is
Maltese: 9/l, l-għadd ta'
English: The pharmacokinetics of topotecan were generally unchanged when co-administered with ranitidine.
Maltese: Ġeneralment, il-farmakokinetika ta' topotecan ma tinbidilx meta topotecan jingħata flimkien ma' ranitidine.
English: In clinical studies,
Maltese: Fl-istudji kliniċi li saru,
English: The safety profile of topotecan when given in combination with cisplatin in the cervical cancer clinical studies is consistent with that seen with topotecan monotherapy.
Maltese: Il-profil tas-sigurtà ta' topotecan meta jingħata flimkien ma' cisplatin fi studji kliniċi tal-kanċer taċċerviċi huwa konsistenti ma' dak li ntwera b'monoterapija ta' topotecan.
English: The overall haematological toxicity is lower in patients treated with topotecan in combination with cisplatin compared to topotecan monotherapy, but higher than with cisplatin alone.
Maltese: It-tossiċità ematoloġika totali hija anqas f'pazjenti trattati b'topotecan flimkien ma' cisplatin meta mqabbla ma' monoterapija b' topotecan, iżda ogħla milli b'cisplatin waħdu.
English: Volume of distribution was slightly decreased and thus half-life only increased by 14%.
Maltese: Il-volum ta' distribuzzjoni naqas ftit u b'hekk il-half-life żdiedet biss b'14 %.
English: The pharmacokinetics of oral topotecan have not been studied in patients with hepatic impairment (see section 4.2 and 4.4).
Maltese: Il-farmakokinetika ta' topotecan mill-ħalq ma ġietx studjata f'pazjenti b'indeboliment tal-kliewi jew tal-fwied (ara sezzjonijiet 4.2 u 4.4)
English: Approximately 20% was excreted as total topotecan and 2% was excreted as N-desmethyl topotecan in the urine.
Maltese: Bejn wieħed u ieħor 20 % tneħħa bħala topotecan totali u 2 % tneħħa bħala N-desmethyl topotecan flawrina.
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion HYCAMTIN 4 mg powder for concentrate for solution for infusion
Maltese: HYCAMTIN 1 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni HYCAMTIN 4 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: Clinical guidelines describing the aggressive management of CTID include specific recommendations on patient communication and awareness, recognition of early warning signs, use of anti-diarrhoeals and antibiotics, changes in fluid intake and diet, and need for hospitalisation (see sections 4.2 and 4.8).
Maltese: Gwidi klinikali li jiddeskrivu l-maniġġjar aggressiv ta' CTID jinkludu rakkomandazzjonijiet speċifiċi dwar il-komunikazzjoni mal-pazjent biex dan ikun jaf x'inhu jiġri, biex jitlemħu s-sinjali tal-bidu tal-kundizzjoni, l-użu ta' mediċini kontra d-dijarea u tal-antibijotiċi, bidliet fil-konsum ta' likwidi u bidliet fid-dieta, u l-bżonn li wieħed jiddaħħal l-isptar (ara sezzjonijiet 4.2 u 4.8).
English: In course 1 the incidence was 20%, by course 4 the incidence was 8%.
Maltese: Fl-ewwel kors l-inċidenza kienet ta' 20 %, sal-kors 4 l-inċidenza kienet ta' 8 %.
English: Resulting from its mechanism of action, topotecan is genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro and mouse bone marrow cells in vivo.
Maltese: Minnħabba l-mod ta' kif jaħdem, topotecan huwa ġenotossiku għal ċelluli mammiferi (ċelluli tallimfoma tal-ġrieden u limfoċiti tal-bnedmin) in vitro u ċelluli tal-mudullun tal-ġrieden in vivo.
English: Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Maltese: Tqabbil ta' parametri farmakokinetiċi ma ssuġġerew l-ebda tibdil fil-farmakokinetika f'perjodu ta' ħamest ijiem ta' dożaġġ.
English: Tel.: +48 22 375 4888
Maltese: Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
English: Anti-tumour activity was demonstrated primarily in patients with neuroblastoma.
Maltese: Attività kontra t-tumur intweriet primarjament f'pazjenti b'newroblastoma.
English: Overdoses have been reported in patients being treated with intravenous topotecan (up to 10 fold of the recommended dose) and topotecan capsules (up to 5 fold of the recommended dose).
Maltese: Dożi eċċessivi ġew irrapportati f'pazjenti li kienu qegħdin jiġu kkurati b'kapsuli ta' topotecan (sa 5 darbiet id-doża rakkomandata) u b'topotecan ġol-vina (sa 10 darbiet id-doża rakkomandata).
English: The recommended monotherapy dose of oral topotecan in patients with small cell lung carcinoma with creatinine clearance between 30 and 49 ml/min is 1.9 mg/m2/day for five consecutive days.
Maltese: Id-doża rakkomandata ta' monoterapija ta' topotecan mill-ħalq f'pazjenti b'karċinoma taċ-ċelluli żżgħar tal-pulmun bi tneħħija tal-krejatinina bejn 30 u 49 ml/min hija ta' 1.9 mg/m2/kuljum għal ħamest ijiem konsekuttivi.
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion topotecan
Maltese: HYCAMTIN 4 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni topotecan
English: Mucosal inflammation
Maltese: Mhux applikabbli
English: Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11% (4% of courses) developed fever and 26% (9% of courses) developed infection.
Maltese: Fost il-pazjenti kollha li kienu kkurati fi studji kliniċi (inklużi kemm dawk b'newtropenja qawwija kif ukoll dawk li ma żviluppawx newtropenja qawwija), 11 % (4 % tal-korsijiet) kellhom ddeni u 26 % (9 % tal-korsijiet) qabdithom infezzjoni.
English: Platelet transfusions were given in 4% of courses.
Maltese: Trasfużjonijiet ta' plejtlits ingħataw f'4 % tal-korsijiet.
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion topotecan
Maltese: HYCAMTIN 1 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni topotecan
English: A major route of clearance of topotecan is by hydrolysis of the lactone ring to form the ring-opened carboxylate.
Maltese: It-tneħħija ta' topotecan sseħħet l-aktar permezz tal-idroliżi tal-lactone ring biex jifforma r-ring-opened carboxylate.
English: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus BSC.
Maltese: Rapporti miġbura mill-pazjenti stess permezz ta' assessjar unblinded urew benefiċju konsistenti fuq sintomi b' topotecan mill-ħalq flimkien ma' BSC.
English: The frequency of some side effects is not known (events from spontaneous reports and the frequency cannot be estimated from the available data):
Maltese: Il-frekwenza ta' xi effetti sekondarji mhijiex magħrufa (avvenimenti minn rapporti spontanji u lfrekwenza ma tistax tiġi stmata mid-data disponibbli):
English: • Inflammation and ulcers of the mouth tongue or gums.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib.
English: In association with severe neutropenia, fever or infection occurred in 16% of patients during course 1 and overall in 23% of patients (6% of courses).
Maltese: Flimkien ma' newtropenja qawwija, kien hemm inċidenza ta' deni jew infezzjoni f'16% tal-pazjenti waqt l-ewwel kors u b'kollox f'23 % talpazjenti (6 % tal-korsijiet).
English: Approximately 51% was excreted as total topotecan and 3% was excreted as N-desmethyl topotecan in the urine.
Maltese: Bejn wieħed u ieħor 51 % tneħħa bħala topotecan totali u 3 % tneħħa bħala N-desmethyl topotecan fl-awrina.
English: Topotecan plus cisplatin had a statistically significant benefit in overall survival relative to cisplatin monotherapy after adjusting for interim analyses (Log-rank p = 0.033).
Maltese: Topotecan flimkien ma' cisplatin kellu benefiċċju fis-sopravivenza totali li kien statitstikament sinifikanti meta mqabbel ma' monoterapija b'cisplatin wara aġġustament għall-analiżi interim (Log-rank p = 0.
English: Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to reduce the dose to maintain neutrophil counts.
Maltese: Il-prattika ta' onkoloġija standard għall-immaniġġjar ta' newtropenija hija jew li tagħti topotecan ma' prodotti mediċinali oħra (eż. G-CSF) jew li tnaqqas id-doża biex iżżomm il-livelli ta' newtrofili.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Red blood cell transfusions were given in 30% of patients (13% of courses).
Maltese: Trasfużjonijiet ta' ċelluli ħomor ingħataw lil 30 % tal-pazjenti (13 % tal-korsijiet).
English: If reconstitution is performed under strict aseptic conditions Hycamtin infusion may be completed within 12 hours at room temperature (or 24 hours if stored at 2-8oC).
Maltese: Jekk it-taħlita tkun magħmula taħt kundizzjonijiet asettiċi stretti, l-infużjoni ta' Hycamtin tista' titlesta fi żmien 12-il siegħa f'temperatura tal-kamra (jew 24 siegħa jekk tkun maħżuna f'temperatura ta' bejn 2-8oC).
English: Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous.
Maltese: Studji pre-klinikali juru li r-rabta ta' topotecan ma' proteini tal-plażma huwa baxx (35 %) u distribuzzjoni bejn ċelluli taddemm u plażma kienet pjuttost omoġeni.
English: Gastrointestinal perforation Hepatobiliary disorders Common
Maltese: Mhux magħruf Perforazzjoni gastro-intestinali Disturbi fil-fwied u fil-marrara Komuni
English: This rare side effect may affect up to 1 in 1,000 people treated with Hycamtin:
Maltese: Dan l-effett sekondarju rari jista' jaffettwa sa persuna 1 minn kull 1,000 ikkurati b'Hycamtin:
English: Topotecan should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Maltese: Topotecan jista' jingħata biss taħt l-osservazzjoni ta' speċjalista li għandu esperjenza fl-użu ta' kimoterapija (ara sezzjoni 6.6).
English: An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma and faeces.
Maltese: Sustanza iffurmata mill-metaboliżmu ta' N-desmethyl, li ntweriet li kellha attività tixtiebaħ jew anqas minn dik tas-sustanza oriġinali f'assay ibbażat fiċ-ċellula, instabet fl-awrina, fil-plasma, u fil-ħmieġ.
English: There is insufficient experience with the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min).
Maltese: M'hemmx biżżejjed esperjenza bl-użu ta' topotecan f'pazjenti b'indeboliment sever tal-funzjoni talkliewi (tneħħija tal-krejatinina ta' < 20 ml/min).
English: Median time to onset of moderate to severe anaemia was day 12 with a median duration of 7 days.
Maltese: Iż-żmien medjan għal bidu ta' anemija moderata sa qawwija kien jum 12 u ħadet medjan ta' sebat ijiem.
English: • Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Maltese: • Uġigħ qawwi fl-istonku, dardir, rimettar tad-demm, ippurgar iswed jew imdemmi (sintomi possibbli ta' perforazzjoni gastro-intestinali).
English: • Mild pain and inflammation at the site of injection.
Maltese: • Sinjali ta' infezzjoni:
English: Hycamtin 1 mg powder for concentrate for solution for infusion should be reconstituted with 1.1 ml of water for injections to provide 1 mg per ml of topotecan.
Maltese: Hycamtin 1 mg trab għal konċentrat għal soluzzjoni għall-infużjoni jrid jiġi rikostituwit ma' 1.1 ml ta' ilma għal injezzjonijiet biex jipprovdi 1 mg ta' topotecan għal kull ml.
English: 1 x 1 mg vial
Maltese: fjala 1 x 1 mg
English: The recommended dose of topotecan is 1.5 mg/m body surface area per day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three-week interval between the start of each course.
Maltese: Id-doża ta' topotecan rakkomandata hija ta' 1.5 mg/m tal-erja tas-superfiċje tal-ġisem kuljum mogħtija b'infużjoni fil-vina għal 30 minuta kuljum għal ħames ġranet konsekuttivi b'intervall ta' tliet ġimgħat bejn il-bidu ta' kull kors.
English: How Hycamtin is given A doctor or nurse will administer Hycamtin as an infusion into your arm lasting about 30 minutes.
Maltese: Tabib jew infermier se jagħtik Hycamtin bħala infużjoni ġo dirgħajk għal perjodu ta' madwar 30 minuta.
English: Median time to onset of severe thrombocytopenia was day 15 with a median duration of 2.5 days.
Maltese: Iżżmien medjan għal bidu ta' tromboċitopenja qawwija kien jum 15 u ħadet medjan ta' 2.5 ġranet.
English: The contents of HYCAMTIN 1 mg vials must be reconstituted with 1.1 ml water for injections.
Maltese: Il-kontenut ta' HYCAMTIN ta' 1 mg iridu jiġu rikostitwiti b'1.1 ml ta' ilma għal injezzjonijiet.
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion
Maltese: HYCAMTIN 4 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: Mucosal inflammation Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4).
Maltese: Topotecan mhuwiex irrakkomandat li jintuża f'dan il-grupp ta' pazjenti (ara sezzjoni 4.4).
English: HYCAMTIN capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Maltese: Pazjenti li qabel kellhom esponiment għal cisplatin jinħtieġu intervall sostnut mingħajr trattament biex jiġġustifika trattament biż-żewġ mediċini flimkien (ara sezzjoni 5.1).
English: Hycamtin 1 mg powder for concentrate for solution for infusion Hycamtin 4 mg powder for concentrate for solution for infusion topotecan
Maltese: Informazzjoni għall-utent Hycamtin 1 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Hycamtin 4 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni topotecan
English: In clinical studies, topotecan was discontinued if the dose needed to be reduced below 1.5 mg/m 2/day.
Maltese: topotecan ma baqax jingħata jekk d-doża tnaqqset għal taħt 1.5 mg/m 2/kuljum.
English: There may be a higher than usual chance of you getting side effects if you are also being treated with cyclosporin A. You will be monitored closely if you are taking both these medicines.
Maltese: Jista' jkun hemm ċans akbar minn normal li jkollok effetti sekondarji jekk qed tirċievi wkoll trattament b'cyclosporin A.
English: In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose.
Maltese: Barra minn hekk, ġew irrapportati enzimi epatiċi elevati b'doża eċċessiva ta' topotecan ġol-vina.
English: 9/l) occurred in 29% of patients in 14% of courses.
Maltese: 9/l) f'29 % tal-pazjenti f'14 % tal-korsijiet. 10 % talpazjenti f'4 % tal-korsijiet ingħataw trasfużjoni ta' plejtlits.
English: In these studies there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Maltese: F'dawn l-istudji ma' kienu jidhru l-ebda differenzi fil-farmakokinetika ta' topotecan fost il-pazjenti tfal, adoloxxenti u adulti ż-żgħar b'tumuri solidi jew lewkimja, iżda t-tagħrif huwa limitat wisq biex tasal għallkonklużjonijiet definiti.
English: If you get the capsule contents in your eyes, wash them immediately with gently flowing water for at least 15 minutes.
Maltese: Jekk iċċappas għajnejk bil-kontenut tal-kapsuli, aħsilhom immedjatament bl-ilma nieżel bil-mod għal 15-il minuta mill-anqas.
English: This should be taken into account when prescribing HYCAMTIN, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
Maltese: Id-doża tiegħek ta' Hycamtin jista' jkun ikollha bżonn tinbidel.
English: Novartis Pharma Services Inc. Τηλ: +357 22 690 690
Maltese: Τηλ: +357 22 690 690
English: Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils <1.5 x 10
Maltese: - Qabel ma bdew l-ewwel kors kellhom depressjoni qawwija tal-mudullun, jiġifieri kellhom linja bażi ta' newtrofili ta' < 1.5 x 10
English: The hazard ratio for survival with IV topotecan relative to CAV was 1.04 (95% CI: 0.78, 1.40).
Maltese: Il-proporzjon ta' periklu għas-sopravivenza b'topotecan li jingħata fil-vina meta mqabbel ma' CAV kien 1.04 (95 % CI:
English: Hard capsule.
Maltese: GĦAMLA FARMAĊEWTIKA Kapsula iebsa.
English: The recommended monotherapy dose of topotecan in patients with ovarian or small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days.
Maltese: Id-doża ta' topotecan rakkomandata f' monoterapija f'pazjenti b'karċinoma tal-ovarji jew taċ-ċelluli ż-żgħar tal-pulmun u li għandhom tneħħija tal-krejatinina ta' bejn l-20 u d-39 ml/min hija ta' 0.75 mg/m2/ġurnata għal ħamest ijiem konsekuttivi.
English: Inhibitors of ABCB1 and ABCG2 administered with oral topotecan have been shown to increase topotecan exposure.
Maltese: Barra minn hekk, ġew irrapportati enzimi epatiċi elevati b'doża eċċessiva ta' topotecon ġol-vina.
English: • if you are breast-feeding.
Maltese: • il-marda li qed tiġi kkurata.
English: Hycamtin helps to destroy tumours.
Maltese: Hycamtin jista' jġiegħel persuni jħossuhom għajjenin.
English: Uncommon side effects
Maltese: Effetti sekondarji komuni ħafna
English: Extravasation
Maltese: Iperbilirubinimja
English: Korean patients with renal impairment had generally higher exposure than non-Asian patients with the same degree of renal impairment.
Maltese: Pazjenti Koreani b'indeboliment renali ġeneralment kellhom espożizzjoni ogħla minn pazjenti mhux Asjatiċi bl-istess grad ta' indeboliment renali.
English: This summary was last updated in April 2017.
Maltese: 'Apri l 2017.
English: The full EPAR for Quadrisol can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: It contains the active substance vedaprofen.
Maltese: Fih is-sustanza attiva vedaprofen.
English: Other information about Quadrisol:
Maltese: Informazzjoni oħra dwar Quadrisol:
English: Why is Quadrisol approved?
Maltese: Għal xiex ġiet approvat Quadrisol?
English: Vedaprofen blocks an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Maltese: Vedaprofen jimblokka enzima msejħa ċikloksiġenażi, li hija involuta fil-produzzjoni tal-prostaglandini.
English: Quadrisol contains vedaprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Quadrisol fih vedaprofen, li jappartjeni għall-klassi ta' mediċini msejħin mediċini antinfjammatorji nonsterojdali (NSAIDs).
English: The European Commission granted a marketing authorisation valid throughout the EU for Quadrisol on 4 December 1997.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Quadrisol valida fl-UE fl-4 ta' Diċembru 1997.
English: The side effects of Quadrisol are typical for those seen with other medicines from this product class (NSAIDs) such as lethargy or damage to (lesions) the mouth, stomach, intestines (including soft stools or diarrhoea) and kidneys.
Maltese: L-effetti sekondarji ta' Quadrisol huma tipiċi għal dawk li dehru f'mediċini oħra minn din il-klassi ta' prodotti (NSAIDs) bħal-letarġija jew ħsara (leżjonijiet) fil-ħalq, fl-istonku, fl-intestini (inkluż ippurgar artab u dijarea) u fil-kliewi.
English: What are the risks associated with Quadrisol?
Maltese: X'inhuma r-riskji assoċjati ma' Quadrisol?
English: In horses, skin rashes (urticaria) have been reported.
Maltese: Fiż-żwiemel, kien irrapportat raxx fil-ġilda (urtikarja).
English: Quadrisol oral gel improved lameness and soft tissue injuries in horses and the response to treatment with Quadrisol was similar to the response to either flunixine meglumine or phenylbutazone, which are other NSAIDs used to treat these conditions.
Maltese: Il-ġell orali Quadrisol tejjeb korrimenti ta' zappip u tat-tessut artab fiż-żwiemel u r-rispons għall-kura bi Quadrisol kien simili għar-rispons ta' fluniksin meglumin jew fenilbutazon, li huma NSAIDs oħra li jintużaw biex jikkuraw dawn il-kundizzjonijiet.
English: This is a summary of the European public assessment report (EPAR) for Quadrisol.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta
English: For the full list of restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: This included studies in a large number of horses with bone, muscle and other soft tissue and joint problems.
Maltese: Dan inkluda studji f'għadd kbir ta' żwiemel bi problemi fl-għadam, fil-muskoli u bi problemi oħra fit-tessut artab fil-ġogi.
English: Quadrisol is a veterinary medicine used in horses to relieve pain and reduce inflammation due to injury to the muscle, bones and joints as well as to other non-bony areas of the body (so called soft tissue lesions).
Maltese: Quadrisol huwa mediċina veterinarja li jintuża fiż-żwiemel biex itaffi l-uġigħ u jnaqqas l-infjammazzjoni permezz ta' korriment fil-muskoli, l-għadam u l-ġogi kif ukoll f'żoni oħra mhux mgħaddma tal-ġisem (imsejħa leżjonijiet ta' tessut artab).
English: How does Quadrisol work?
Maltese: Dan l-użu ta' Quadrisol.
English: Under
Maltese: IV.
English: Annex II
Maltese: Anness II
English: − combination products containing domperidone/cinnarizine
Maltese: − prodotti kkombinati li fihom domperidone/cinnarizine
English: Doc ID:LMD21025;EDMS-ERI-47362001 2 Englert W, Schlich D. A double-blind crossover trial of domperidone in chronic postprandial dyspepsia.
Maltese: EDMS-ERI-47362001 2 Englert W, Schlich D. A double-blind crossover trial of domperidone in chronic postprandial dyspepsia.
English: The CMDh agreed to:
Maltese: Is-CMDh qabel li:
English: o Is not favourable for the combination domperidone/cinnarizine.
Maltese: o Mhuwiex favorevoli għall-kombinazzjoni domperidone/cinnarizine.
English: • Nausea and vomiting of functional, organic, infectious or dietetic origin
Maltese: • Dardir u rimettar ta' oriġini funzjonali, organiku, infettiv jew dijetetiku
English: CMDh position
Maltese: Pożizzjoni tas-CMDh
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for domperidonecontaining medicinal products.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali li fihom domperidone.
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC, the PRAC recommends:
Maltese: Għalhekk, skont l-Artikolu 116 tad-Direttiva 2001/83/KE, il-PRAC jirrakkomanda:
English: Domperidone is a peripheral dopamine D2-receptor antagonist with gastrokinetic and anti-emetic properties.
Maltese: Domperidone huwa antagonist tar-riċettur-D2 periferali tad-dopamina bi proprjetajiet gastrokinetiċi u antiemetiċi.
English: • dopamine agonists (such as L-dopa and bromocriptine) used in the treatment of Parkinson's disease
Maltese: • agonisti ta' dopamine (bħal L-dopa u bromocriptine) użati fil-kura tal-marda ta' Parkinson
English: 1 - PRAC recommendation
Maltese: 1 - Rakkomandazzjoni tal-PRAC
English: o Is not favourable for high dose rectal formulations (60 mg) or rectal formulations approved for paediatric use (10 mg).
Maltese: o Mhuwiex favorevoli għall-formulazzjonijiet tar-rektum ta' doża għolja (60 mg) jew formulazzjonijiet tar-rektum approvati għall-użu pedjatriku (10 mg).
English: • radiotherapy or drug therapy
Maltese: • radjuterapija jew terapija b'mediċina
English: − rectal formulations dosed at 10 mg and 60 mg
Maltese: − formulazzjonijiet tar-rektum b'doża 10 mg u 60 mg