FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Budesonide/Formoterol Teva contains lactose')
Maltese: - Is-sustanza l-oħra hi lactose monohydrate (ara sezzjoni 2 taħt ‘ Budesonide/Formoterol Teva fih
English: Each dose contains approximately 10 milligrams of lactose (as monohydrate) .
Maltese: Kull doża fiha bejn wieħed u ieħor 10 milligrammi ta' lactose (bħala monohydrate).
English: - The active substances are budesonide and formoterol fumarate dihydrate.
Maltese: - Is-sustanzi attivi huma budesonide u formoterol fumarate dihydrate.
English: Budesonide/Formoterol Teva pharmacokinetic profile
Maltese: Profil farmakokinetiku ta' Budesonide/Formoterol Teva
English: The mean number of days on oral corticosteroids/patient during the 12 months was slightly reduced in the budesonide/formoterol group (7-8 days/patient/year compared with 11-12 and 9-12 days in the placebo and formoterol groups, respectively).
Maltese: In-numru medju ta' ġranet fuq kortikosterojdi orali/pazjent matul it-12-il xahar kien daqsxejn anqas fil-grupp li ħa budesonide/formoterol (7-8 jiem/pazjent/sena meta mqabbel ma' 11-12 u 9-12 jiem fil-gruppi li ħadu plaċebo u formoterol, rispettivament).
English: 1 inhalation (actuation), twice a day.
Maltese: 1 jew 2 inalazzjonijiet (attwazzjonijiet), darbtejn kuljum.
English: <1/10), uncommon (1/1,000, < 1/100), rare (1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: 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) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Headache, tremor Dizziness Taste disturbances
Maltese: Uġigħ ta' ras, tregħid Sturdament Disturbi fit-togħma
English: Budesonide/Formoterol Teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Maltese: Budesonide/Formoterol Teva hu ndikat għat-trattament regolari tal-ażma, fejn l-użu ta' kombinazzjoni (kortikosterojd li jittieħed man-nifs u agonist tal-adrenoriċetturi β2 li jaħdem fit-tul) ikun adattat:
English: The mean number of exacerbations per year (as defined above) was significantly reduced with budesonide/formoterol as compared with treatment with formoterol alone or placebo (mean rate 1.4 compared with 1.8-1.9 in the placebo/formoterol group).
Maltese: In-numru medju ta' taħrixiet kull sena (kif definiti hawn fuq) tnaqqas b'mod sinifikanti b'budesonide/formoterol meta mqabbel mal-kura b'formoterol waħdu jew plaċebo (rata medja ta' 1.4 meta mqabbel ma' 1.8-1.9 fil-grupp li ħa plaċebo/formoterol).
English: Other medicines and Budesonide/Formoterol Teva
Maltese: Mediċini oħra u Budesonide/Formoterol Teva
English: Mild irritation in the throat, coughing, hoarseness Bronchospasm
Maltese: Irritazzjoni ħafifa fil-gerżuma, sogħla, ħanqa
English: Hypersensitivity to the active substances or the excipient listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għall-eċċipjent elenkat fis-sezzjoni 6.1.
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem,The Netherlands
Maltese: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Il-Pajjiżi l-Baxxi
English: Asthma Budesonide/formoterol maintenance therapy
Maltese: Budesonide/Formoterol
English: The safety and efficacy of Budesonide/Formoterol Teva in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Budesonide/Formoterol Teva fit-tfal, sa 12-il sena u l-adolexxenti, minn 13 sa 17-il sena ma ġewx determinati s'issa.
English: Possible systemic effects include Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Maltese: L-effetti sistemiċi possibbli jinkludu s-sindrome ta' Cushing, karatteristiċi Cushingoid, soppressjoni adrenali, dewmien fit-tkabbir tat-tfal u adolexxenti, tnaqqis fid-densità minerali talgħadam, katarretti u glawkoma.
English: Contains lactose.
Maltese: Tliet snin.
English: Budesonide undergoes an extensive degree (approximately 90%) of biotransformation on first passage through the liver to metabolites of low glucocorticosteroid activity.
Maltese: Budesonide jgħaddi minn grad estensiv (madwar 90%) ta' bijotrasformazzjoni mal-ewwel passaġġ mill-fwied għal metaboliti ta' attività glukokortikosterojdi baxxa.
English: Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only.
Maltese: Budesonide/Formoterol Teva hu indikat għall-użu fl-adulti ta' 18-il sena u aktar, biss.
English: • Use Budesonide/Formoterol Teva every day.
Maltese: • Uża Budesonide/Formoterol Teva kuljum.
English: Budesonide/Formoterol Teva 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate
Maltese: Budesonide/Formoterol Teva 160 mikrogramma/4.5 mikrogrammi trab li jittieħed man-nifs budesonide/ formoterol fumarate dihydrate
English: How to use Budesonide/Formoterol Teva (page 8) 4.
Maltese: Kif għandek tuża Budesonide/Formoterol Teva (paġna 8)
English: Adults (18 years and older): 1 inhalation twice daily
Maltese: Adulti (18-il sena u iktar): 2 inalazzjonijiet darbtejn kuljum
English: The effects include: - changes in bone mineral density (thinning of the bones) - cataract (clouding of the lens in the eye) - glaucoma (increased pressure in the eye) - a slowing of the rate of growth of children and adolescents - an effect on the adrenal gland (a small gland next to the kidney)
Maltese: L-effetti jinkludu: - bidliet fid-densità minerali tal-għadam (traqqiq tal-għadam) - katarretti (tidnis tal-lenti fil-għajn) - glawkoma (żieda fil-pressjoni tal-għajn)
English: If the patient experiences paradoxical bronchopasm Budesonide/Formoterol Teva should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Maltese: Jekk il-pazjent jesperjenza bronkospażmu paradossali, Budesonide/Formoterol Teva għandu jiġi mwaqqaf immedjatament, il-pazjent għandu jiġi valutat u jekk ikun meħtieġ, tinbeda terapija alternattiva.
English: Budesonide/Formoterol Teva 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Maltese: Budesonide/Formoterol Teva 320 mikrogramma/9 mikrogrammi trab li jittieħed man-nifs budesonide/ formoterol fumarate dihydrate
English: Limited data about this interaction for high-dose inhaled budesonide indicates that marked increases in plasma levels (on average four fold) may occur if itraconazole, 200 mg once daily, is administered concomitantly with inhaled budesonide (single dose of 1000 micrograms).
Maltese: Dejta limitata dwar din l-interazzjoni għal budesonide ta' doża għolja li jittieħed man-nifs tindika li jista' jkun hemm żidiet qawwija fil-livelli fil-plażma (medja ta' erba' darbiet aktar) jekk itraconazole, 200 mg darba kuljum, jingħata fl-istess ħin ma' budesonide li jittieħed man-nifs (doża waħda ta' 1000 mikrogramma).
English: Pneumonia in patients with COPD
Maltese: Pulmonite f'pazjenti b'COPD
English: • Pneumonia (infection to the lung) in COPD patients.
Maltese: • Pulmonite (infezzjoni tal-pulmun) f'pazjenti b'COPD (effett sekondarju komuni)
English: Contents of the pack and other information What Budesonide/Formoterol Teva contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X' fih Budesonide/Formoterol Teva
English: Budesonide/Formoterol Teva 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate
Maltese: Budesonide/Formoterol Teva 160 μg/4.5 μg trab li jittieħed man-nifs budesonide/formoterol fumarate dihydrate
English: Budesonide/Formoterol Teva is NOT indicated for use in children 12 years of age and younger or adolescents 13 to 17 years of age.
Maltese: Budesonide/Formoterol Teva mhuwiex indikat għall-użu fi tfal ta' 12-il sena u iżgħar jew f'adolexxenti, minn 13 sa 17-il sena.
English: Budesonide/Formoterol Teva 320 mcg/9 mcg inhalation powder budesonide/formoterol fumarate dihydrate
Maltese: Budesonide/Formoterol Teva 320 μg/9 μg trab li jittieħed man-nifs budesonide/formoterol fumarate dihydrate
English: Budesonide/Formoterol Teva is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Maltese: Budesonide/Formoterol Teva jittieħed bħala kura regolari ta' manteniment ma' bronkodilatur separat li jaħdem malajr bħala inalatur ta' solliev.
English: How to use Budesonide/Formoterol Teva (page 9) 4.
Maltese: Kif għandek tuża Budesonide/Formoterol Teva (paġna 9)
English: Budesonide/Formoterol Teva is indicated for use in adults 18 years of age and older only.
Maltese: Budesonide/Formoterol Teva huwa indikat għall-użu f'persuni adulti minn 18-il sena 'l fuq biss.
English: You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
Maltese: Inti allerġiku għal budesonide, formoterol fumarate dihydrate, jew is-sustanza l-oħra ta' din ilmediċina (elenkati fis-sezzjoni 6).
English: Hypokalaemia Hyperglycaemia
Maltese: Kortikosterojdi f'dożi għoljin
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Maltese: M'hemm l-ebda evidenza klinika konklussiva għal differenzi bejn il-klassijiet fid-daqs tar-riskju ta' pulmonite fost il-prodotti ta' kortikosterojdi li jinġibdu man-nifs.
English: In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
Maltese: Fi studji farmakokinetiċi bi u mingħajr imblokk bil-faħam, Budesonide/Formoterol Teva ġie evalwat billi tqabbel ma' prodott li jittieħed man-nifs ta' kombinazzjoni b'doża fissa awtorizzat alternattiv li fih l-istess sustanzi attivi, budesonide u formoterol u ntwera li huwa ekwivalenti kemm fl-esponiment sistemiku (sigurtà) kif ukoll fid-depożitu fil-pulmuni (effikaċja).
English: Budesonide/Formoterol Teva 320 micrograms/9 micrograms inhalation powder
Maltese: Budesonide/Formoterol Teva 320 mikrogramma/9 mikrogrammi trab li jittieħed man-nifs
English: Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Maltese: Kull doża mogħtija (miġbuda man-nifs) fiha 320 mikrogramma ta' budesonide u 9 mikrogrammi ta' formoterol fumarate dihydrate.
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland.
Maltese: L-Irlanda Unit 27/35, IDA Industrial Park, Cork Road, Waterford, L-Irlanda
English: Budesonide/Formoterol Teva 320 micrograms/9 micrograms should be used as maintenance therapy only.
Maltese: Budesonide/Formoterol Teva 320 mikrogramma/9.0 mikrogrammi għandu jintuża bħala terapija ta' manteniment biss.
English: Each delivered (inhaled) dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Maltese: Kull doża mogħtija (miġbuda man-nifs) fiha 160 mikrogramma ta' budesonide u 4.5 mikrogrammi ta' formoterol fumarate dihydrate.
English: No data on fertility are available.
Maltese: Mhix disponibbli dejta dwar il-fertilità.
English: • Increased mucus production, change in mucus colour
Maltese: • żieda fil-produzzjoni tal-mukus, bidla fil-kulur tal-mukus
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with Budesonide/Formoterol Teva .
Maltese: Ladarba s-sintomi tal-ażma jiġu kkontrollati, tista' tingħata kunsiderazzjoni sabiex gradwalment titnaqqas id-doża ta' Budesonide/Formoterol Teva.
English: Gastrointestinal disorders Uncommon
Maltese: Disturbi gastro-intestinali
English: Adults (18 years and older): 2 inhalations twice a day.
Maltese: Adulti (18-il sena u aktar) 2 inalazzjonijiet darbtejn kuljum.
English: Cataract and glaucoma
Maltese: F' dan il-fuljett
English: Budesonide/Formoterol Teva 160 micrograms / 4.5 micrograms inhalation powder
Maltese: Budesonide/Formoterol Teva 160 mikrogramma/4.5 mikrogrammi trab li jittieħed man-nifs.
English: How to store Budesonide/Formoterol Teva (page 19) 6.
Maltese: Kif taħżen Budesonide/Formoterol Teva (paġna 19) Kontenut tal-pakkett u informazzjoni oħra (paġna 19)
English: How to store Budesonide/Formoterol Teva (page 21) 6.
Maltese: Kif taħżen Budesonide/Formoterol Teva (paġna 21) Kontenut tal-pakkett u informazzjoni oħra (paġna 22)
English: Do not use Budesonide/Formoterol Teva 320/9 micrograms as a ‘reliever inhaler'.
Maltese: Tużax Budesonide/Formoterol Teva 320/9 mikrogrammi bħala inalatur ta' solljiev.
English: • Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide and procainamide).
Maltese: • Mediċini għal taħbit tal-qalb mgħaġġel jew irregolari (bħal quinidine, disopyramide u procainamide).
English: Budesonide/Formoterol Teva is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled short-acting β2 adrenoreceptor agonists.
Maltese: Budesonide u formoterol ma kienu osservati li jinteraġixxu mal-ebda prodott mediċinali ieħor użat filkura tal-ażma.
English: Candida infections in the oropharynx, pneumonia (in COPD patients)
Maltese: Infezzjonijiet b'candida fl-orofarinġi, pulmonite (f'pazjenti b'COPD)
English: Preparing your new Budesonide/Formoterol Teva
Maltese: Terapija ta' manteniment b'Budesonide/Formoterol Teva
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċjuu rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tarriskji).
English: Package leaflet: Information for the patient Budesonide/Formoterol Teva 160 micrograms/4.5 micrograms, inhalation powder
Maltese: Informazzjoni għall-pazjent Budesonide/Formoterol Teva 160 mikrogramma/4.5 mikrogrammi, trab li jittieħed man-nifs
English: How to store Budesonide/Formoterol Teva
Maltese: Uża Budesonide/Formoterol Teva tiegħek kuljum.
English: Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Maltese: Din id-differenza mhijiex ikkunsidrata li għandha impatt fuq is-sigurtà klinika.
English: Package leaflet: Information for the patient Budesonide/Formoterol Teva 320 micrograms/9 micrograms, inhalation powder
Maltese: Informazzjoni għall-pazjent Budesonide/Formoterol Teva 320 mikrogramma/9 mikrogrammi, trab li jittieħed man-nifs
English: Pharmacokinetic parameters for the respective substances were comparable after the administration of budesonide and formoterol as monoproducts or as the fixed-dose combination.
Maltese: Il-parametri farmakokinetiċi għas-sustanzi rispettivi kienu komparabbli wara l-għoti ta' budesonide u formoterol bħala monoprodotti jew bħala l-kombinazzjoni b'doża fissa.
English: Budesonide/Formoterol Teva contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Maltese: Budesonide/Formoterol Teva fih formoterol u budesonide, li għandhom modi ta' azzjoni differenti u juru effetti addittivi f'termini tat-tnaqqis fit-taħrix tal-ażma.
English: • The mouthpiece will still ‘click' even when your Spiromax is empty.
Maltese: • Il-biċċa tal-ħalq xorta se ‘tfaqqa' anki meta l-iSpiromax tiegħek ikun vojt.
English: • Medicines like digoxin, often used to treat heart failure.
Maltese: • Mediċini bħal digoxin, sikwit użati għall-kura ta' insuffiċjenza tal-qalb.
English: Outcome of a procedure under Article 107 of Directive 2001/
Maltese: Riżultat ta' proċedura skont l-Artikolu 107 tad-Direttiva 2001/83/KE
English: 13 February 2012
Maltese: 13 ta' Frar 2012
English: What is buflomedil?
Maltese: X'inhi l-buflomedil?
English: Buflomedil is authorised in Austria, Belgium, Cyprus, France, Germany Luxembourg, the Netherlands, Poland, Portugal and Spain, under the invented na trade names.
Maltese: Il-buflomedil huwa awtorizzat fl-Awstrija, fil-Belġju, f'Ċipru, fi Franza, filĠermanja, fil-Greċja, fl-Italja, fil-Lussemburgu, fil-Pajjiżi l-Baxxi, fil-Polonja, fil-Portugall u fi Spanja, taħt l-isem ivvintat Loftyl u ismijiet kummerċjali oħra.
English: Why was buflomedil reviewed?
Maltese: Għalfejn ġiet riveduta il-buflomedil?
English: Buflomedil is a vasoactive agent, a medicine which has an effect on blood c increases the blood flow to the brain and other parts of the body by widening the bl used to treat the symptoms of peripheral arterial occlusive disease (PAOD), a cond the legs.
Maltese: Tintuża għall-kura tas-sintomi tal-marda okklussiva arterjali periferali (peripheral arterial occlusive disease - PAOD), kundizzjoni li fiha, l-arterji l-kbar tal-ġisem jinstaddu u jikkawżaw sintomi bħal uġigħ u dgħufija, b'mod partikolari fir-riġlejn.
English: Questions and answers on the suspension of buflomedilcontaining medicines
Maltese: Mistoqsijiet u tweġibiet dwar is-sospensjoni tal-mediċini li fihom il-buflomedil
English: This included data from clinical trials with buflomedil, post-marketing surveillance s neurological and cardiac side effects in patients when g dose and the dose that s, which are ties to minimise the risks, serious side effects continue to be reported.
Maltese: Din kienet tinkludi dejta minn provi kliniċi bil-buflomedil, is-sorveljanza ta' wara t-tqegħid fis-suq u rriċensjoni ppubblikata, kif ukoll minn ċentri tal-kontroll tal-veleni fl-Ewropa rigward każi ta' avvelenament serju kaġun tal-buflomedil.
English: France had previously taken d not been sufficient to e 107, France informed the CHMP of its latest action to suspend the marketing mmittee could prepare an opinion on whether the marketing authorisations for products containing buflomedil should be maintained, changed, suspended or
Maltese: Kif jitlob l-Artikolu 107, Franza informat lis-CHMP bl-aktar azzjoni reċenti tagħha li tissospendi lawtorizzazzjonijiet għat-tqegħid fis-suq fi Franza, biex b'hekk il-Kumitat ikun jista' jħejji opinjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti li fihom il-buflomedil għandhomx jinżammu, jinbidlu, jiġu sospiżi jew irtirati fl-UE kollha.
English: The European Medicines Agency has completed a review of the safety and effectiveness of buflomedilboth oral and injectable, due to serious side effects seen with buflomedil.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni tas-sigurtà u tal-effikaċja ta' mediċini li fihom ilbuflomedil, kemm dawk orali kif ukoll dawk injettabli, minħabba l-effetti sekondarji serji li dehru bilbuflomedil.
English: These included neurological disorders such as convulsions and status epilepticus (a dangerous condition where the brain is in a persistent state of seizure), and cardiac disorders such as accelerated heart rate and cardiac arrest.
Maltese: Dawn kienu jinkludu disturbi newroloġiċi bħal konvulżjonijiet u status epilepticus (kundizzjoni perikoluża fejn il-moħħ ikun fi stat persistenti ta' aċċessjonijiet), u disturbi kardijaċi bħal rata tal-qalb mgħaġġla u attakk tal-qalb.
English: These included changes to the packaging and p recommendations on adjusting the dose for patients with kidney problems and restr medicines' use in certain patients (for instance pati such measures in 1998 and 2006, but concluded in February 2011 that these ha prevent serious side effects from occurring in France.
Maltese: Franza kienet ħadet dawn il-miżuri fl-1998 u fl-2006, iżda fi Frar 2011 ikkonkludiet li dawn ma kinux biżżejjed biex jipprevjenu ċerti effetti sekondarji serji fi Franza.
English: These include managing underlying health problems which can increase the risk of PAOD, such as diabetes, high cholesterol, high blood pressure as well as smoking.
Maltese: Dan jinkludi l-kura ta' problemi tas-saħħa sottostanti li jistgħu jżidu r-riskju ta' PAOD, bħal dijabete, kolesterolu għoli, pressjoni għolja tad-demm kif ukoll tipjip.
English: It may harm them,
Maltese: − vuċi mibdula (ħanqa);
English: Respiratory depression Bradypnoea
Maltese: Depressjoni respiratorja Bradipnea
English: Deep CNS depression:
Maltese: Depressjoni tas-CNS profonda:
English: 58, rue du Pont de Créteil 94100 Saint-Maur-Des-Fossés - France
Maltese: 58, rue du Pont de Créteil 94100
English: Sedatives (central nervous system depressants)
Maltese: Sedattivi (depressanti tas-sistema nervuża ċentrali)
English: − a feeling of spinning (vertigo);
Maltese: − sensazzjoni ta' tidwir (vertigo);
English: The bioavailability is 100% at the action site.
Maltese: Bijodisponibilità Il-bijodisponibilità hija 100% fis-sit ta' azzjoni.
English: METHOD OF ADMINISTRATION
Maltese: Metodu ta' amministrazzjoni
English: Diplopia (paralysis of oculomotor muscles)
Maltese: Diplopja (paraliżi tal-muskoli okulomutur)
English: Neuropathy4 :
Maltese: Newropatija4 :
English: In severe cases, respiratory arrest may occur.
Maltese: F'każijiet severi, jista' jkun hemm arrest respiratorju.
English: Maximum recommended dosage:
Maltese: Doża massima rakkomandata:
English: The frequencies classification follows the 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) and Very rare (<1/10,000).
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) u Rari ħafna(< 1/10,000).
English: Apnoea (respiratory arrest) Yawning
Maltese: Apnea (arrest respiratorju) Titwib
English: Mepivacaine is an amide local anaesthetic.
Maltese: Il-mepivacaine huwa anestetiku lokali amide.
English: Each ml contains 0.11 mmol of sodium (2.467 mg/ml).
Maltese: Kull ml fih 0.11 mmol ta' sodju (2.467 mg/ml).
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: Il-barcode 2D jġorr l-identifikatur uniku inkluż.
English: Recommended therapeutic dose:
Maltese: Doża terapewtika rakkomandata:
English: The maximum recommended dose in pediatric population is 3 mg of mepivacaine/kg (0.1 ml mepivacaine/kg).
Maltese: Id-doża massima rakkomandata fil-popolazzjoni pedjatrika hija ta' 3 mg ta' mepivacaine/kg (0.1 ml mepivacaine/kg).
English: Reporting of suspected adverse reactions
Maltese: Rapportar ta' reazzjonijiet avversi ssuspettati
English: Tachyarrhythmia (including ventricular extrasystoles and ventricular fibrillation)5
Maltese: Takiarritmija (inklużi extrasystoles ventrikulari u fibrillazzjoni ventrikulari)5 Angina pectoris 6
English: Box containing 50 cartridges.
Maltese: Kaxxa li fiha 50 kartriġ.
English: − euphoric mood, anxiety/nervousness;
Maltese: − burdata ewforika, ansjetà/nervożità;
English: Epileptic patients:
Maltese: Pazjenti epilettiċi:
English: Weight (kg)
Maltese: (kg)
English: Mepivacaine hydrochloride dose (mg)
Maltese: Doża tal-kloridrat talmepivacaine (mg)
English: Pulp anaesthesia generally lasts approximately 25 minutes after maxillary infiltration and around 40 minutes after inferior alveolar block, whereas anaesthesia of soft tissue was maintained around up to 90 minutes after maxillary infiltration and approximatively 165 minutes after inferior alveolar nerve block.
Maltese: minuta wara imblokkar alveolari inferjuri, filwaqt li l-anestesija tat-tessuti rotob inżammet sa 90 minuta wara infiltrazzjoni maxellari u bejn wieħed u ieħor 165 minuta wara blokk tan-nervituri inferjuri alveolari.
English: Not known Myocardial depression
Maltese: Depressjoni mijokardijaka