FrancophonIA/ELRC3.0 huggingface dataset:
English: Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.14 mg of sodium in 0.3 mL.
Maltese: Aranesp 30 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 1.14 mg ta' sodium f'0.3 mL.
English: Aranesp 150 micrograms solution for injection in pre-filled syringe 0.3 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Maltese: Aranesp 150 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Soluzzjoni għall-injezzjoni ta' 0.3 mL (500 mcg/mL darbepoetin alfa) f'siringa mimlija għal-lest magħmula minn ħġieġ tip 1 b'labra tal-azzar li ma jissaddadx ta' ħxuna 27.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 50 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Maltese: Aranesp, 50 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Darbepoetin alfa
English: Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 2.27 mg of sodium in 0.6 mL.
Maltese: Aranesp 300 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 2.27 mg ta' sodium f'0.6 mL.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/051 1 pack
Maltese: FIS-SUQ EU/1/01/185/051 - Pakkett ta' 1
English: Aranesp 100 micrograms solution for injection in vial 1 mL solution for injection (100 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer laminated elastomeric stopper and an aluminium seal with flip-off dust cover.
Maltese: Aranesp 100 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Soluzzjoni għall-injezzjoni ta' 1 mL (100 mcg/mL darbepoetin alfa) f'kunjett magħmul minn ħġieġ tip 1 b'tap magħmul minn fluoropolymer u lastku laminat u siġill tal-aluminju b'għatu flip-off. Daqs tal-pakkett ta' kunjett wieħed jew 4 kunjetti.
English: EU/1/01/185/103 4 pack
Maltese: EU/1/01/185/004
English: Aranesp 300 micrograms solution for injection in pre-filled syringe 0.6 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Maltese: Aranesp 300 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Soluzzjoni għall-injezzjoni ta' 0.6 mL (500 mcg/mL darbepoetin alfa) f'siringa mimlija għal-lest magħmula minn ħġieġ tip 1 b'labra tal-azzar li ma jissaddadx ta' ħxuna 27.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/055 1 pack
Maltese: FIS-SUQ EU/1/01/185/055 - Pakkett ta' 1
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 mL pre-filled pen contains 60 micrograms darbepoetin alfa (200 micrograms/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pinna mimlija għal-lest ta' 0.3 mL fiha 60 mikrogramma darbepoetin alfa (200 mikrogramma/mL).
English: Aranesp 130 micrograms solution for injection in pre-filled syringe 0.65 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Maltese: Aranesp 130 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Soluzzjoni għall-injezzjoni ta' 0.65 mL (200 mcg/mL darbepoetin alfa) f'siringa mimlija għal-lest magħmula minn ħġieġ tip 1 b'labra tal-azzar li ma jissaddadx ta' ħxuna 27.
English: Aranesp 130 micrograms solution for injection pre-filled pen EU/1/01/185/072 - 1 pack
Maltese: Aranesp 130 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest EU/1/01/185/072 - Pakkett ta' 1
English: Step 3: Inject G Hold the stretch or pinch.
Maltese: • Evita li tinjetta f'żoni b'ċikatriċi jew stretch marks.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 300 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Maltese: Aranesp, 300 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Aranesp 500 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Maltese: Aranesp, 500 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Darbepoetin alfa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/110 1 pack
Maltese: FIS-SUQ EU/1/01/185/110
English: EU/1/01/185/058 4 pack
Maltese: EU/1/01/185/040
English: Aranesp 10 micrograms solution for injection in pre-filled syringe 0.4 mL solution for injection (25 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Maltese: Aranesp 10 mikrogrammi soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Soluzzjoni għall-injezzjoni ta' 0.4 mL (25 mcg/mL darbepoetin alfa) f'siringa mimlija għal-lest magħmula minn ħġieġ tip 1 b'labra tal-azzar li ma jissaddadx ta' ħxuna 27.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/048 1 pack
Maltese: FIS-SUQ EU/1/01/185/048 - Pakkett ta' 1
English: a Hypersensitivity events includes all events under the hypersensitivity SMQ.
Maltese: L-avvenimenti ta' sensittività eċċessiva jinkludu l-avvenimenti kollha taħt l-SMQ tas-sensittività eċċessiva.
English: The frequency of all hypersensitivity reactions was estimated from clinical trial data as very common in cancer patients.
Maltese: Il-frekwenza hija stmata minn data minn provi kliniċi bħala mhux komuni f'pazjenti bil-kanċer.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 100 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Maltese: Aranesp, 100 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Darbepoetin alfa
English: Aranesp 10 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 1.52 mg of sodium in 0.4 mL.
Maltese: Aranesp 10 mikrogrammi soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 1.52 mg ta' sodium f'0.4 mL.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/053 1 pack
Maltese: FIS-SUQ EU/1/01/185/053 - Pakkett ta' 1
English: 1 ADRs identified in the post marketing environment.
Maltese: Emorraġija fis-sit tal-injezzjoni 1 ADRs identifikati fl-ambjent ta' wara t-tqegħid fis-suq.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 10 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Maltese: Aranesp, 10 mikrogrammi soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Darbepoetin alfa
English: d Dialysis vascular access thrombosis includes all adverse reactions under the dialysis vascular access thrombosis
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/054 1 pack
Maltese: FIS-SUQ EU/1/01/185/054 - Pakkett ta' 1
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/047 1 pack
Maltese: FIS-SUQ EU/1/01/185/047 - Pakkett ta' 1
English: EU/1/01/185/001 1 pack EU/1/01/185/002 4 pack EU/1/01/185/074 1 pack with needle guard EU/1/01/185/075 4 pack with needle guard
Maltese: EU/1/01/185/074 pakkett b'għatu ta' protezzjoni tal-labra ta' 1 EU/1/01/185/075 pakkett b'għatu ta' protezzjoni tal-labra ta' 4
English: • Stomach area (abdomen), except for a 5 cm (2-inch) area right around your navel
Maltese: • Iż-żona tal-istonku (addome), minbarra żona ta' 5 ċm (2 pulzieri) eżatt madwar iż-żokra tiegħek
English: In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and 5.1).
Maltese: F'pazjenti b'rispons batut ta' emoglobina għal epoetins, spjegazzjonijiet alternattivi għar-rispons batut għandhom jiġu kkunsidrati (ara sezzjonijiet 4.2 u 5.1).
English: Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Maltese: Trattament ta' anemija sintomatika f'pazjenti adulti bil-kanċer li għandhom tumuri malinni mhux majelojdi li qed jirċievu 'kimoterapija.
English: EU/1/01/185/019 1 pack EU/1/01/185/020 4 pack EU/1/01/185/094 1 pack with needle guard EU/1/01/185/095 4 pack with needle guard
Maltese: EU/1/01/185/094 pakkett b'għatu ta' protezzjoni tal-labra ta' 1 EU/1/01/185/095 pakkett b'għatu ta' protezzjoni tal-labra ta' 4
English: Aranesp 40 micrograms solution for injection pre-filled pen EU/1/01/185/049 - 1 pack
Maltese: Aranesp 40 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest EU/1/01/185/049 - Pakkett ta' 1
English: EU/1/01/185/011 1 pack EU/1/01/185/012 4 pack EU/1/01/185/084 1 pack with needle guard EU/1/01/185/085 4 pack with needle guard
Maltese: EU/1/01/185/084 pakkett b'għatu ta' protezzjoni tal-labra ta' 1 EU/1/01/185/085 pakkett b'għatu ta' protezzjoni tal-labra ta' 4
English: Yellow window (injection complete)
Maltese: Tieqa safra (injezzjoni kompluta)
English: EU/1/01/185/013 1 pack EU/1/01/185/014 4 pack EU/1/01/185/086 1 pack with needle guard EU/1/01/185/087 4 pack with needle guard
Maltese: EU/1/01/185/086 pakkett b'għatu ta' protezzjoni tal-labra ta' 1 EU/1/01/185/087 pakkett b'għatu ta' protezzjoni tal-labra ta' 4
English: EU/1/01/185/069 1 pack EU/1/01/185/070 4 pack EU/1/01/185/092 1 pack with needle guard EU/1/01/185/093 4 pack with needle guard
Maltese: EU/1/01/185/092 pakkett b'għatu ta' protezzjoni tal-labra ta' 1 EU/1/01/185/093 pakkett b'għatu ta' protezzjoni tal-labra ta' 4
English: A rise in haemoglobin of greater than 2 g/dL (1.25 mmol/L) over a four week period should be avoided.
Maltese: Għandha tiġi evitata żieda fl-emoglobina ta' aktar minn 2 g/dL (1.25 mmol/L) fuq perjodu ta' erba' ġimgħat.
English: Serum potassium levels should be monitored regularly during Aranesp therapy.
Maltese: Il-livelli ta' potassium fis-serum għandhom jiġu mmonitorjati b'mod regolari waqt terapija b'Aranesp.
English: Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.52 mg of sodium in 0.4 mL.
Maltese: Aranesp 80 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 1.52 mg ta' sodium f'0.4 mL.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/049 1 pack
Maltese: FIS-SUQ EU/1/01/185/049 - Pakkett ta' 1
English: 0.6 ml (10 mg/ml)
Maltese: 0.6 mL (10 mg/mL) Siringa mimlija għallest
English: 6 mg
Maltese: 6 mg Soluzzjoni għal injezzjoni
English: Subcutaneous use pre-filled syringe (glass)
Maltese: Siringa mimlija għallest (ħġieġ)
English: Ref. EMEA/374268/2007
Maltese: EMEA/374268/2007
English: London, 16 August 2007 Doc.
Maltese: Londra, 16 t'Awissu 2007 Dok. Ref.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: International non-proprietary name (INN): garenoxacin mesylate
Maltese: Mhux-Patentat (INN): garenoxacin
English: In almost all studies, it was compared with other antibiotics (clarithromycin, co-amoxiclav, amoxicillin, levofloxacin, ceftriaxone, erythromycin, azithromycin, piptazobactam or metronidazole).
Maltese: Kważi fl-istudji kollha, hija ġiet imqabbla ma' antibijotiċi oħra (clarithromycin, co-amoxiclav, amoxicillin, levofloxacin, ceftriaxone, erythromycin, azithromycin, piptazobactam jew metronidazole).
English: • complicated intra-abdominal infections, including infections after surgery and acute infections of the pelvis.
Maltese: • infezzjonijiet intra-addominali ikkumplikati, inklużi infezzjonijet wara l-kirurġija u infezzjonijiet akuti tal-pelvi.
English: What is Garenoxacin mesylate?
Maltese: X'inhi Garenoxacin mesylate?
English: Garenoxacin mesylate is an antibiotic that belongs to the ‘quinolone' class.
Maltese: Garenoxacin mesylate hija antibijotiku li jappartjeni għall-klassi ta'‘quinolone'.
English: Garenoxacin mesylate is a medicine that was to be available as tablets (400 mg and 600 mg) and as a solution for infusion (drip into a vein).
Maltese: Garenoxacin mesylate hija mediċina li kellha tkun disponibbli bħala pilloli (400 mg u 600 mg) u bħala soluzzjoni għal infużjoni (drip ġol-vina).
English: Garenoxacin mesylate was examined in 19 studies involving a total of over 7,000 patients with the types of bacterial infection that the medicine was expected to be used to treat.
Maltese: Garenoxacin mesylate ġiet eżaminata fi 19-il studju li involvew total ta' fuq 7,000 pazjenti bit-tipi ta' infezzjonijiet batteriċi li l-mediċina kienet mistennija li titratta.
English: On 25 July 2007, Schering-Plough Europe officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Garenoxacin mesylate 400 mg and 600 mg film-coated tablets and 2 mg/ml solution for infusion, for the treatment of bacterial infections.
Maltese: Fil-25 ta' Lulju 2007, Schering-Plough Europe innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq tal-pilloli miksija b'rita ta' 400 mg u ta' 600 mg u soluzzjoni ta' 2 mg/ml għal infużjoni Garenoxacin mesylate, għat-trattament ta' infezzjonijiet batteriċi.
English: What were the reasons given by the company to withdraw the application?
Maltese: F'liema fażi kienet waslet l-evalwazzjoni meta l-applikazzjoni ġiet irtirata?
English: The application was at day 180 when the company withdrew.
Maltese: L-applikazzjoni kienet f'jum 180 meta l-kumpanija irtirat.
English: • acute bacterial exacerbation (flare-up) of chronic bronchitis (long-lasting inflammation of the airways in the lungs),
Maltese: • taħrix batteriku akut (flare-up) ta' bronkite kronika (infjammazzjoni tal-passaġġi ta' l-arja filpulmuni li ddum ħafna),
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Maltese: Wara li CHMP evalwa r-reazzjonijiet millkumpanija għal-lista ta' mistoqsijiet, kien għad hemm xi argumenti mhux solvuti pendenti.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Garenoxacin mesylate?
Maltese: X'inhuma l-konsegwenzi ta' l-irtirar għal pazjenti li għaddejjin minn provi kliniċi b'Garenoxacin mesylate?
English: The effects of Garenoxacin mesylate were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Garenoxacin mesylate ġew l-ewwel ittestjati f'mudelli esperimentali qabel ma ġew studjati fil-bnedmin.
English: Garenoxacin mesylate was expected to be used to treat adults with the following infections:
Maltese: Garenoxacin mesylate kienet mistennija li tintuża biex titratta adulti bl-infezzjonijiet li ġejjin:
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: Ladarba l-kumpanija tkun forniet ir-reazzjonijiet għall-mistoqsjiet, is-CHMP jirrevedihom u jista', qabel tagħti opinjoni, jistaqsi xi mistoqsijiet li jkun għad fadal f'jum 180.
English: • acute bacterial sinusitis (short-lived infection of the sinuses, air-filled passageways in the bones around the nose and eyes),
Maltese: • sinużite batterika akuta (infezzjoni ta' qasir żmien tas-sinusis, passaġġi mimlija bl-arja flgħadam madwar l-imnieħer u l-għajnejn),
English: Furthermore, the CHMP had concerns over the side effects of Garenoxacin mesylate, particularly a risk of low blood pressure.
Maltese: Barra minn hekk, isCHMP kien imħasseb fuq l-effetti sekondarji ta' Garenoxacin mesylate, partikolarment ir-riskju ta' pressjoni tad-demm baxxa.
English: • infections of the skin and the tissue just below the skin, including foot infections in patients with diabetes,
Maltese: • infezzjonijiet tal-ġilda u tat-tessuti eżatt taħt il-ġilda, inklużi infezzjonijiet fis-saqajn f'pazjenti bid-dijabete,
English: How is Garenoxacin mesylate expected to work?
Maltese: Kif inhi mistennija li taħdem Garenoxacin mesylate?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Garenoxacin mesylate could not have been approved for the treatment of bacterial infections.
Maltese: Għaldaqstant, fiż-żmien ta' l-irtirar, l-opinjoni tas-CHMP kienet li l-benefiċċju ta' Garenoxacin mesylate ma ntweriex biżżejjed u li xi benefiċċji ma kinux ta' importanza akbar mir-riskji identifikati.
English: [carton only]:
Maltese: [kartuna biss]:
English: FI-02200 Espoo Finland
Maltese: FI-02200
English: For severe hepatic impairment see section 4.3.
Maltese: Għall-indeboliment epatiku sever ara sezzjoni 4.3.
English: - Pheochromocytoma.
Maltese: - Fejokromoċitoma.
English: The INR values increased on average by 13% [CI90 6-19%].
Maltese: Il-valuri ta' INR żdiedu b'medja ta' 13% [CI90 6-19%].
English: PC: {number} SN: {number} < NN: {number} >
Maltese: {numru} < NN: {numru} >
English: Myocardial infarction**
Maltese: Infart mijokardijaku**
English: Date of first authorisation: 24 August 2011 Date of latest renewal: 26 May 2016
Maltese: Data tal-aħħar tiġdid: 26 meiju 2016
English: Dose reduction may be needed (see section 5.2).
Maltese: Jista' jkun hemm bżonn ta' tnaqqis fid-doża (ara sezzjoni 5.2).
English: Hepatitis with mainly cholestatic features (see section 4.4)*
Maltese: Epatite l-aktar b'fatturi kolestatiċi (ara sezzjoni 4.4)*
English: Urticaria*
Maltese: Urtikarja*
English: Picture 1
Maltese: Stampa 1
English: Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19); see section 4.5.
Maltese: Entacapone wera ftit jew l-ebda inibizzjoni tat-tipi loħra ta' isoenzimi P450 (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A u CYP2C19); ara sezzjoni
English: Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 ~ 4 µM).
Maltese: Data minn studji in vitro bl-użu ta' preparazzjonijiet ta' mikrożomi epatiċi umani tindika li entacapone jinibixxi ċ-ċitokromju P450 2C9 (IC50 ~ 4 µM).
English: 2D barcode carrying the unique identifier included [carton only]
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż [kartuna biss]
English: Label Orion Corporation
Maltese: Tikketta Orion Corporation
English: In the second study, the mean proportion of daily ON time increased by 4.5% (CI95% 0.93%, 7.97%) from baseline.
Maltese: Fit-tieni studju, il-proporzjon medju tal-perjodu ON ta' kuljum żdied b'4.5% (CI95% 0.93%, 7.97%) mill-linja bażi.
English: Chromaturia*
Maltese: Kromaturja*
English: Muscle, musculoskeletal and connective tissue pain*
Maltese: Uġigħ fil-muskoli, muskolu-skeletriku u tat-tessuti konnettivi*
English: Chest pain, peripheral oedema, fall, gait disturbance, asthenia, fatigue
Maltese: Uġigħ fis-sider, edima periferali, waqgħat, disturbi fil-mixja, astenja, għeja
English: 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or
Maltese: 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg jew
English: Neuroleptic malignant syndrome*
Maltese: Sindrome newrolettiku malinn*
English: Dopamine dysregulation syndrome is mentioned in the product information of other dopaminergic medication used in Parkinson's disease such as levodopa/carbidopa, apomorphine, levodopa/benserazide, rotigotine and ropinirole.
Maltese: Is-sindrome ta' indeboliment fir-regolazzjoni ta' dopamine huwa msemmi fl-informazzjoni tal-prodott ta' mediċini dopaminerġiċi oħra użati fil-marda ta' Parkinson bħal levodopa/carbidopa, apomorphine, levodopa/benserazide, rotigotine, u ropinirole.
English: Colitis*, dysphagia
Maltese: Kolite*, disfaġja
English: Depression, hallucination, confusional state*, abnormal dreams*, anxiety, insomnia
Maltese: Depressjoni, alluċinazzjonijiet, stat konfuż*, ħolm mhux normali*, ansjetà, insomnja
English: Orion Pharma (Ireland) Ltd. c/o Allphar Services Ltd. Tel: +353 1 428 7777
Maltese: Orion Pharma (Ireland) Ltd. c/o Allphar Services Ltd.
English: Entacapone is almost completely metabolized prior to excretion via urine (10 to 20%) and bile/faeces (80 to 90%).
Maltese: Entacapone jiġi metabolizzat kważi kompletament qabel ma jitneħħa fl-awrina (10 sa 20%) u fil-bili/ħmieġ (80 sa 90%).
English: Pharmacotherapeutic group: anti-parkinson drugs, dopa and dopa derivatives, ATC code: N04BA03
Maltese: Kategorija farmakoterapewtika: mediċini kontra l-marda ta' Parkinson, dopa u derivattivi ta' dopa, Kodiċi ATC:
English: See picture 1.
Maltese: Ara stampa 1.
English: Red iron oxide (E172)
Maltese: Iron oxide aħmar (E172)
English: Metabolism and nutrition disorders Common:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni:
English: - The active substances of Levodopa/Carbidopa/Entacapone Orion are levodopa, carbidopa and entacapone.
Maltese: - Is-sustanzi attivi ta' Levodopa/Carbidopa/Entacapone Orion huma levodopa, carbidopa u entacapone.
English: Muscle spasms, arthralgia
Maltese: Spażmi fil-muskoli, artralġja
English: Ischemic heart disease events other than myocardial infarction (e.g. angina pectoris)**, irregular heart rhythm
Maltese: Avvenimenti ta' mard iskemiku tal-qalb minbarra infart mijokardijaku (eż. anġina pektoris)**, ritmu tal-qalb mhux regolari
English: In the first study, entacapone increased the mean daily ON time by 1 h 20 min (CI 95% 45 min, 1 h 56 min) from baseline.
Maltese: Fl-ewwel studju, entacapone żied il-medja tal-perjodu ON ta' kuljum b'1 h 20 min (CI 95% 45 min, 1 h 56 min) mill-linja bażi.
English: NMS, including rhabdomyolysis and hyperthermia, is characterised by motor symptoms (rigidity, myoclonus, tremor), mental status changes (e.g., agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase.
Maltese: NMS, inkluż rabdomijolisi u ipertermja, hija kkarratterizzata minn sintomi motorji (riġidità, mijoklonus, tregħid), tibdil fl-istat mentali (eż., aġitazzjoni, konfużjoni, koma), ipertermja, disfunzjoni awtonomika (takikardija, pressjoni tad-demm mhux stabbli) u creatine phosphokinase fis-serum għoli.
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose
Maltese: Levodopa/Carbidopa/Entacapone Orion fih sucrose
English: However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for Rwarfarin increased on average by 18% [CI90 11-26%].
Maltese: Iżda, fi studju dwar l-interazzjoni f'voluntiera f'saħħithom, entacapone ma biddilx il-livelli fil-plażma ta' S-warfarin, filwaqt li l-AUC ta' R-warfarin żdiedet b'medja ta' 18% [CI90 11-26%].
English: Yellow iron oxide (E172)
Maltese: Iron oxide isfar (E172)
English: - Narrow-angle glaucoma.
Maltese: - Żomm dan il-fuljett.
English: Label 10 tablets 30 tablets 100 tablets 130 tablets 175 tablets 250 tablets
Maltese: Tikketta 10 pilloli 30 pillola 100 pillola 130 pillola 175 pillola 250 pillola
English: Gastrointestinal haemorrhage
Maltese: Disturbi gastro-intestinali
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli, peress li ma tista' tiġi derivata l-ebda stima valida minn provi kliniċi jew minn studji epidemjoloġiċi).