FrancophonIA/ELRC3.0 huggingface dataset:
English: White, round, biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘2.5' on the other side.
Maltese: Pilloli bojod, tondi, bikonvessi, miksija b'rita, imnaqqxa b'‘APO' fuq naħa waħda u ‘OLA' fuq ‘2.5' fuq in-naħa l-oħra.
English: Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna) jinkludu titbaxxa t-temperatura normali tal-ġisem; rittmi mhux normali tal-qalb; mewt għall-għarrieda u inspjegabbli; infjammazjoni tal-frixa li tikkawża wġigħ qawwi fl-istonku, deni u taqlib; mard tal-fwied li jidher bħala sfurija talġilda u tal-abjad tal-għajnejn; mard fil-muskoli li jippreżenta ruħu bħala wġigħ li m'għandux spjegazzjoni; u erezzjoni mtawla u/jew bl-uġigħ.
English: Rhabdomyolysis
Maltese: TAGĦRIF
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 15 mg ta' olanzapine.
English: Management
Maltese: MANIFATTURI
English: • Olanzapine Apotex 15 mg orodispersible tablets are available in blisters packs of 28 tablets.
Maltese: • Olanzapine Apotex 15 mg pilloli li jinħallu fil-ħalq huma disponibbli f'pakketti bil-folji ta' 28 pillola.
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high
Maltese: 3 Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 5.17 mmol/l) li żdiedu għal għoljin
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 7.5 mg film-coated tablets
Maltese: Olanzapine Apotex 7.5 mg pilloli miksija b'rita
English: Stuttering
Maltese: Treddigħ
English: • Each Olanzapine Apotex 5 mg film-coated tablet contains 5 mg olanzapine.
Maltese: • Kull Olanzapine Apotex 5 mg pillola li tinħall fil-ħalq fiha 5 mg ta' olanzapine.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/635/001
English: 28 orodispersible tablets 56 orodispersible tablets
Maltese: 56 pillola miksija b'rita
English: Olanzapine Apotex belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
Maltese: Olanzapine Apotex huwa fil-grupp ta' mediċini msejħa antipsikotiċi u hija użata fil-kura ta' dawn il-kondizzjonijiet li ġejjin:
English: NV Apotex SA
Maltese: Jekk tieqaf tieħu Olanzapine Apotex
English: If you take more Olanzapine Apotex than you should Patients who have taken more Olanzapine Apotex than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Maltese: Jekk tieħu Olanzapine Apotex aktar milli suppost Pazjenti li ħadu iżjed Olanzapine Apotex milli suppost kellhom dawn is-sintomi li ġejjin: taħbit mgħaġġel tal-qalb, aġitazzjoni/aggressività, problemi biex jitkellmu, movimenti mhux tas-soltu (speċjalment tal-ħalq u ta' l-ilsien) u tnaqqis fil-livell ta' koxjenza.
English: Rhabdomyolysis11
Maltese: Diskineżja tardiva11
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Maltese: Każijiet rari li ġew irrappurtati bħala NMS kienu rrappurtati f'assoċjazzjoni ma' olanzapine ukoll. Manifestazzjonijiet kliniċi ta' NMS huma deni għoli, ebusija tal-muskoli, stat mentali alterat u evidenza ta' instabbiltà awtonomika (pressjoni tad-demm jew tal-polz irregolari, takikardija, għaraq eċċessiv, u taħbit tal-qalb irregolari).
English: EU/1/10/635/010-011 EU/1/10/635/018
Maltese: EU/1/10/635/018
English: INFORMATION IN BRAILLE Olanzapine Apotex 10 mg film-coated tablet
Maltese: INFORMAZZJONI BIL-BRAILLE Olanzapine Apotex 10 mg pillola li tinħall fil-ħalq
English: Mean infant exposure (mg/kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/kg).
Maltese: L-espożizzjoni (mg/kg) medja fit-trabi fl-istat fiss kienet stmata li kienet 1.8% tad-doża ta' olanzapine fl-omm.
English: INFORMATION IN BRAILLE Olanzapine Apotex 2.5 mg film-coated tablet UNIQUE IDENTIFIER - 2D BARCODE
Maltese: INFORMAZZJONI BIL-BRAILLE Olanzapine Apotex 2.5 mg pillola miksija b'rita
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 2.5 mg film-coated tablets
Maltese: Olanzapine Apotex 2.5 mg pilloli miksija b'rita
English: • Olanzapine Apotex 15 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘15' on the other side
Maltese: • Olanzapine Apotex 15 mg pilloli li jinħallu fil-ħalq huma sofor, tondi, ċatti, b'tarf radjali, imnaqqxa b''APO' fuq naħa waħda u ‘OL' fuq ‘15' fuq in-naħa l-oħra.
English: Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Maltese: Olanzapine wera wkoll vantaġġ statistiku u sinifikanti fuq il-plaċebo filprevenzjoni, kemm f'attakki ġodda ta' manija kif ukoll f'attakki ġodda ta' depressjoni.
English: • Olanzapine Apotex 7.5 mg film-coated tablets are available in blisters packs of 28 and 56 tablets.
Maltese: • Olanzapine Apotex 7.5 mg pilloli miksija b'rita huma disponibbli f'pakketti bil-folji ta' 28 u 56
English: Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Maltese: L-età ta' > 75 sena u ddemenzja tat-tip vaskulari jew imħallta kienu identifikati bħala fatturi ta' riskju għal CVAE f'assoċjazzjoni ma' kura b'olanzapine.
English: The major circulating metabolite is the 10-N-glucuronide, which does not pass the blood brain barrier.
Maltese: Il-prodott metaboliku li l-aktar jiċċirkola huwa 10-N-glukoronide, li ma jaqsamx il-barriera bejn id-demm u lmoħħ.
English: • Olanzapine Apotex 10 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘10' on the other side.
Maltese: • Olanzapine Apotex 10 mg pilloli li jinħallu fil-ħalq huma sofor, tondi, ċatti, b'tarf radjali, imnaqqxa b''APO' fuq naħa waħda u ‘OL' fuq ‘10' fuq in-naħa l-oħra.
English: INFORMATION IN BRAILLE Olanzapine Apotex 5 mg film-coated tablet
Maltese: INFORMAZZJONI BIL-BRAILLE Olanzapine Apotex 5 mg pillola li tinħall fil-ħalq
English: Seizures where in most cases a history of seizures or risk factors for seizures were reported
Maltese: Disturb fid-diskors kien ukoll spiss rappurtat.
English: In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it cannot be concluded at present that olanzapine produces less tardive dyskinesia and/or other tardive extrapyramidal syndromes.
Maltese: Fl-assenza ta' tagħrif iddettaljat li fil-passat kien hemm disturbi akuti u movimenti tardivi ekstrapiramidali, fil-preżent ma jistax wieħed jikkonkludi li olanzapine jipproduċi anqas diskineżja tardiva u/jew sindromi ekstrapiramidali tardivi oħra.
English: • Each Olanzapine Apotex 5 mg orodispersible tablet contains 5 mg olanzapine.
Maltese: • Kull Olanzapine Apotex pillola miksija b'rita 5 mg fiha 5 mg ta' olanzapine.
English: • Each Olanzapine Apotex 10 mg orodispersible tablet contains 10 mg olanzapine.
Maltese: • Kull Olanzapine Apotex pillola miksija b'rita 10 mg fiha 10 mg ta' olanzapine.
English: Olanzapine orodispersible tablet is bioequivalent to olanzapine film-coated tablets, with a similar rate and extent of absorption.
Maltese: Olanzapine pillola li tinħall fil-ħalq hi bijoekwivalenti għal olanzapine pilloli miksija, b'rata u bi grad simili ta' assorbiment.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/010-011 EU/1/10/635/018 BATCH NUMBER
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/635/010-011
English: In renally impaired patients (creatinine clearance <10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hrs) or clearance (21.2 versus 25.0 l/hr).
Maltese: F'pazjenti b'mard tal-kliewi (tneħħija tal-krejatinina < 10 ml/min) f'paragun ma' pazjenti b'saħħithom, ma kienx hemm differenza sinifikanti fil-medja tal-half life ta' l-eliminazzjoni (37.7 kontra
English: INFORMATION IN BRAILLE Olanzapine Apotex 20 mg orodispersible tablet
Maltese: INFORMAZZJONI BIL-BRAILLE Olanzapine Apotex 20 mg pillola li tinħall fil-ħalq
English: Olanzapine Apotex has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Maltese: Ġie muri li Olanzapine Apotex jippreveni li dawn is-sintomi jerġgħu jseħħu f'pazjenti bipolari, fejn lepisodju ta' manija rrisponda għall-kura b'olanzapine.
English: Ref. EMEA/245771/2008
Maltese: EMEA/402811/2008
English: International non-proprietary name (INN): tigecycline
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): tigecycline
English: It contains the active substance tigecycline.
Maltese: Fih is-sustanza attiva tigecycline.
English: The active substance in Tygacil, tigecycline, belongs to the group of antibiotics called ‘glycylcyclines', which are similar to tetracycline.
Maltese: Is-sustanza attiva fi Tygacil, tigecycline tagħmel parti mill-grupp ta' antibijotiċi imsejħa ‘glycylcylines' li huma simili għal tetracycline.
English: What is Tygacil?
Maltese: X'inhu Tygacil?
English: On 22 April 2008, Wyeth Europa Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Tygacil, in the treatment of community-acquired pneumonia.
Maltese: Fit-22 ta' April 2008, Wyeth Europa Limited għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għal indikazzjoni ġdida għal Tygacil fit-trattament ta' pnewmonja akkwiżita fil-komunità.
English: Both studies compared Tygacil with levofloxacin (another antibiotic).
Maltese: Iż-żewġ studji ipparagunaw Tygacil ma' levofloxacin (antibijotiku ieħor).
English: The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation.
Maltese: Is-CHMP normalment idum 90 ġurnata sakemm jadotta opinjoni wara li jkun irċieva applikazzjoni għal modifika fl-awtorizzazzjoni għat-tqegħid fis-suq.
English: Tygacil is an antibiotic that is already used to treat adults with complicated infections of the skin or soft tissue (the tissue below the skin) and complicated infections in the abdomen.
Maltese: Tygacil huwa antibijotiku li qiegħed diġà jintuża biex jitratta adulti b'infezzjonijiet kumplikati tal-ġilda jew tat-tessut artab (it-tessut taħt il-ġilda) u infezzjonjiet ikkumplikati fl-addome.
English: The effectiveness of Tygacil was tested in two main studies involving a total of 846 adults who needed treatment in hospital for community-acquired pneumonia.
Maltese: L-effikaċja ta' Tygacil ġiet ittestjata f'żewġ studji ewlenin li kienu jinvolvu total ta' 846 adult li kellhom bżonn trattament fi sptar għall-pnewmonja akkwiżita fil-komunità.
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 Tygacil could not have been approved for the treatment of community-acquired pneumonia.
Maltese: Skond l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u kellu opinjoni proviżorja li Tygacil ma setax jiġi approvat għattrattament ta' pnewmonja akkwiżita fil-komunità.
English: Tigecycline works by blocking the bacteria's ribosomes, the parts of the bacterial cells where new proteins are made.
Maltese: Tigecycline jaħdem billi jimblokka ir-ribosomi talbatterji, il-partijiet taċ-ċelloli tal-batterji fejn jiġu prodotti proteini ġodda.
English: What was Tygacil expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Tygacil?
English: The effects of Tygacil were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Tygacil għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma' ġew studjati filbniedem.
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 s-CHMP kien evalwa ttweġibiet mill-kumpanija għal lista ta' mistoqsijiet, kien għad fadal xi kwistjonijiet pendent li baqgħu ma ġewx solvuti.
English: Community-acquired pneumonia is usually caused by infection with bacteria.
Maltese: Il-pnewmonja akkwiżita filkomunità hija ġeneralment ikkawżata minn infezzjoni bil-batterji.
English: What are the consequences of the refusal for patients in clinical trials using Tygacil?
Maltese: X'inhuma l-konsegwenzi tar-rifjut għall-pazjenti fil-provi kliniċi li jkunu qed jużaw Tygacil?
English: Tygacil was also expected to be used to treat adults with community-acquired pneumonia.
Maltese: Tygacil kien ukoll mistenni li jintuża sabiex jitratta adulti b'pnewmonja akkwiżita fil-komunità.
English: How is Tygacil expected to work?
Maltese: Kif kien mistenni li jaħdem Tygacil?
English: Tygacil is a powder that is made up into a solution for infusion (drip into a vein).
Maltese: Tygacil huwa trab li huwa magħmul f'soluzzjoni għall-infużjoni (drip fil-vina).
English: The application was at day 150 when the company withdrew.
Maltese: L-applikazzjoni kienet waslet f'jum 150 meta l-kumpanija rtiratha.
English: By blocking the production of new proteins, the bacteria cannot multiply and they eventually die.
Maltese: Billi l-produzzjoni ta' proteini ġodda tiġi imblukkata, il-batterji ma jkunux jistgħu jimmultiplikaw u eventwalment imutu.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for TYGACIL
Maltese: MISTOQSIJA U TWEĠIBA DWAR L-IRTIRAR TA' L-APPLIKAZZJONI GĦAL MODIFIKA FL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ għal TYGACIL
English: What is happening for Tygacil for treatment of complicated skin and soft tissue infections and complicated infections in the abdomen?
Maltese: X'se jiġri għal Tygacil għat-trattament ta' infezzjonijiet ikkumplikati fil-ġilda u fit-tessut artab u għat-trattament ta' infezzjonijiet ikkumplikati fl-addome?
English: Further information on Procoralan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Procoralan.
Maltese: ema.europa.eu/medicines/human/EPAR/Procoralan.
English: Procoralan contains the active substance ivabradine.
Maltese: Procoralan fih is-sustanza attiva ivabradine.
English: Other information about Procoralan
Maltese: Informazzjoni oħra dwar Procoralan
English: Procoralan received a marketing authorisation valid throughout the EU on 25 October 2005.
Maltese: Procoralan irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU fil-25 ta' Ottubru 2005.
English: It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as amlodipine (another medicine used to treat angina) in a study of 1,195 patients.
Maltese: Din kienet effettiva daqs atenolol (imblukkatur tar-riċetturi beta) fi studju ta' 939 pazjent u effettiva daqs amlodipine (mediċina oħra li tintuża biex tikkura l-anġina) fi studju ta' 1,195 pazjent.
English: It also concluded that Procoralan was effective in long-term heart failure with an acceptable safety profile.
Maltese: Din ikkonkludiet ukoll li Procoralan kien effettiv f'insuffiċenza kardijaka fit-tul bi profil tas-sigurtà aċċettabbli.
English: What are the risks associated with Procoralan?
Maltese: X'inhuma r-riskji assoċjati ma' Procoralan?
English: The active substance in Procoralan, ivabradine, works by blocking the ‘If currents' in the sinus node, the ‘pacemaker' for the heart that controls the heart's contractions and regulates the heart rate.
Maltese: Is-sustanza attiva f'Procoralan, l-ivabradine, taħdem billi timblokka l-“kurrenti If” fin-nodi tas-sinus, il-“pacemaker” għall-qalb li jikkontrolla l-kontrazzjonijiet tal-qalb u jirregola t-taħbit tal-qalb.
English: Procoralan was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Maltese: Procoralan tqabbel mal-plaċebo fi studju ewlieni wieħed li inkluda aktar minn 6,500 pazjent b'insuffiċjenza kardijaka fit-tul moderata sa severa.
English: A sixth study compared Procoralan with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Maltese: Is-sitt studju qabbel Procoralan mal-plaċebo fi 19,102 pazjenti b'marda tal-arterja koronarja u mingħajr insuffiċjenza kardijaka klinika.
English: Procoralan is available as tablets (5 and 7.5 mg) and it can only be obtained with a prescription.
Maltese: Procoralan jiġi bħala pilloli (5 u 7.5 mg) u dan jista' jinkiseb biss b'riċetta ta' tabib.
English: How is Procoralan used?
Maltese: Procoralan?
English: Results showed that Procoralan was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Procoralan died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Maltese: Ir-riżultati wrew li Procoralan kien aktar effikaċi mill-plaċebo fil-prevenzjoni tal-mewt minħabba mard tal-qalb jew fil-vażi jew dħul fl-isptar minħabba laggravar tal-insuffiċjenza kardijaka: 24.5 % (793 minn 3,241) tal-pazjenti kkurati bi Procoralan mietu jew iddaħħlu l-isptar minħabba aggravar tal-insuffiċjenza kardijaka, meta mqabbla ma' 28.7 % (937 minn 3,264) tal-pazjenti li rċevew il-plaċebo.
English: In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates).
Maltese: F'dan l-istudju, sottogrupp speċifiku ta' pazjenti li kellhom anġina sintomatika kellhom żieda żgħira iżda sinifikanti fir-riskju kkombinat ta' mewt kardjovaskulari jew attakk tal-qalb mhux fatali bi Procoralan meta mqabbel mal-plaċebo (rati ta' inċidenza ta' 3.4 % fis-sena meta mqabbla ma' 2.9 %).
English: Procoralan must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Maltese: Procoralan m'għandux jintuża f'pazjenti li r-rata tat-taħbit tal-qalb tagħhom waqt l-irpoż tkun taħt is70 taħbita fil-minuta, li jkollhom pressjoni tad-demm baxxa ħafna, diversi tipi ta' disturbi fil-qalb (inkluż xokk kardjoloġiku, disturbi ritmiċi, attakk tal-qalb, insuffiċjenza kardijaka mhux stabbli jew akuta (f'daqqa) u anġina mhux stabbli) jew problemi severi fil-fwied.
English: The most common side effect with Procoralan (which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Maltese: L-effett sekondarju l-aktar komuni bi Procoralan (li jista' jaffettwa aktar minn 1 minn kull 10) huwa fenomeni mdawla jew “fosfeni” (dawl temporanju fil-kamp viżiv).
English: The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Maltese: Id-doża tal-bidu rrakkomandata hija 5 mg darbtejn kuljum mal-ikliet, li t-tabib jista' jżid għal 7.5 mg darbtejn kuljum jew inaqqas għal 2.5 mg (nofs pillola ta' 5 mg) darbtejn kuljum skont ir-rata tat-taħbit tal-qalb u s-sintomi tal-pazjent.
English: However, a fifth study in 728 patients showed that adding Procoralan to amlodipine did not provide an additional benefit.
Maltese: Madankollu, il-ħames studju f'728 pazjent wera li ż-żieda ta' Procoralan ma' amlodipine ma pprovdietx benefiċċju addizzjonali.
English: Procoralan is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).The medicine is used in patients who have a normal heart rhythm, and whose heart rate is at least 70 beats per minute.
Maltese: Procoralan jintuża wkoll f'pazjenti b'insuffiċjenza kardijaka fit-tul (meta l-qalb ma tkunx tista' tippompja biżżejjed demm lill-bqija tal-ġisem) li għandhom ritmu tal-qalb normali u li r-rata tat-taħbit tal-qalb tagħhom hija tal-inqas 75 taħbita fil-minuta.
English: In a fourth study in 889 patients, Procoralan was more effective than placebo, when both were added to atenolol.
Maltese: Fir-raba' studju fi 889 pazjent, Procoralan kien aktar effettiv mill-plaċebo, meta t-tnejn li huma żdiedu ma' atenolol.
English: Bradycardia (slow heart rate) is common (it may affect up to 1 in 10 people).
Maltese: Il-bradikardija (rata tat-taħbit tal qalb bil-mod) hija komuni (din tista' taffettwa sa 1 minn kull 10).
English: It is used in combination with standard therapy including beta blockers, or in patients who cannot be treated with beta blockers.
Maltese: Dan jintuża flimkien ma' terapija standard li tinkludi imblokkaturi tar-riċetturi beta, jew f'pazjenti li ma jistgħux jiġu kkurati b'imblokkaturi tarriċetturi beta.
English: Procoralan was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Maltese: Procoralan tqabbel mal-plaċebo (kura finta) u kuri oħra f'ħames studji ewlenin li involvew aktar minn 4,000 adult b'anġina stabbli fit-tul.
English: In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used.
Maltese: F'pazjenti li għandhom ‘il fuq minn 75 sena, tista' tintuża doża tal-bidu iżjed baxxa ta' 2.5 mg darbtejn kuljum.
English: As for all medicines, data on the use of Procoralan are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Procoralan hija ssorveljata kontinwament.
English: Procoralan must not be taken with a number of other medicines.
Maltese: Procoralan m'għandux jittieħed ma' numru ta' mediċini oħra.
English: The full EPAR for Zubsolv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Zubsolv buprenorphine / naloxone
Maltese: Zubsolv buprenorfina / nalossina
English: Zubsolv is a ‘hybrid medicine'.
Maltese: Zubsolv huwa “mediċina ibrida”.
English: Zubsolv is available as tablets of various strengths (0.7 mg/0.18 mg, 1.4 mg/0.36 mg, 2.9 mg/0.71 mg, 5.7 mg/1.4 mg, 8.6 mg/2.1 mg, 11.4 mg/2.9 mg).
Maltese: 71 mg, 5.7 mg/1.4 mg, 8.6 mg/2.1 mg, 11.4 mg/2.9 mg).
English: Other information about Zubsolv
Maltese: Informazzjoni oħra dwar Zubsolv
English: This is a summary of the European public assessment report (EPAR) for Zubsolv.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zubsolv.
English: The reference medicine for Zubsolv is Suboxone.
Maltese: Il-mediċina ta' referenza għal Zubsolv hija Suboxone.
English: Zubsolv is a medicine used in adults and adolescents aged over 15 years to treat dependence on opioid (narcotic) drugs such as heroin or morphine.
Maltese: Zubsolv hu mediċina użata fl-adulti u fl-adolexxenti li għandhom iktar minn 15-il sena biex tiġi kkurata d-dipendenza fuq mediċini opjojdi (narkotiċi) bħall-eroina jew il-morfina.
English: Why is Zubsolv approved?
Maltese: Għaliex ġie approvat Zubsolv?