FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Recuvyra is a clear, colourless to light yellow solution containing 50 mg of fentanyl (the active substance) per ml of solution.
Maltese: U INGREDJENT(I) OĦRA Recuvyra hija ċara, bla kulur għal isfar ċar li fih 50 mg ta' fentanyl (is-sustanza attiva) għal kull ml ta' soluzzjoni.
English: Middleton Close
Maltese: Priestley Road
English: Slovenská republika (Slovac Republic) Eli Lilly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10
Maltese: Slovenija (Slovenia) Eli Lilly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10
English: Kölblgasse 8-10
Maltese: 8 sa 49.6
English: Tell your veterinarian if your dog is sick or was recently ill, if it has ever had breathing, heart or blood pressure problems or epilepsy, if it has ever had bowel or kidney problems or problems with its eyes, and what medicines your dog has taken, especially within the last month.
Maltese: Għarraf lill-veterinarju tiegħek jekk il-kelb tiegħek kienx marid jew kienx reċentement marid, jekk qatt kellu xi problemi tal-qalb jew tal-pressjoni, jew epilessija, jew jekk qattx kellu problemi fl-imsaren jew tal-kliewi jew problemi f'għajnejh u liema mediċini l-kelb tiegħek kien qed jieħu, speċjalment flaħħar xahar.
English: Fentanyl very commonly causes dose-dependent sedation in dogs which is associated with potential decreased food and water intake, decreased stool production and transient weight loss.
Maltese: F'każ ta' espożizzjoni aċċidentali ta' ħwejjeġ protettivi għall-prodott mediċinali veterinarju, neħħi lħwejjeġ kontaminati minnufih.
English: Store vial upright with the adaptor attached.
Maltese: Żomm il-kunjett miftuħ mal-adapter f'pożizzjoni wieqfa.
English: Place applicator tip at an approximate 45º angle directly onto the skin in the dorsal scapular region.
Maltese: Applikazzjoni topika waħda tipprovdi serħan mill-uġigħ għal tal-anqas 4 ijiem.
English: Fentanyl exerts its analgesic action by binding to and activating µ (mu) opioid receptors that are predominantly found in the pain regulating areas of the brain and spinal cord.
Maltese: Tużax f'każijiet ta' sensittività eċċessiva għas-sustanza attiva, sustanzi mhux attivi jew sustanzi oħra.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL- AWTORIZZAZZJONI
English: EU/1/19/1387/001 EU/1/19/1387/002
Maltese: EU/1/1/19/1387/002
English: The systemic clearance is 18 - 64 mL/min/kg.
Maltese: It-tneħħija sistemika hija ta' 18 - 64 mL/min/kg.
English: Senstend is a combination of two medicines: lidocaine and prilocaine.
Maltese: Senstend huwa kombinazzjoni ta' żewġ mediċini: lidocaine u prilocaine.
English: Frequency of the adverse reactions is defined as: 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).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija ddefinita 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), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Plethora Pharma Solutions Ltd. 32 Merrion Street Upper Dublin 2
Maltese: 32 Merrion Street Upper Dublin 2
English: Methaemoglobinaemia may be accentuated in patients already taking medicinal products known to induce the condition, e.g. sulphonamides, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenobarbital, phenytoin, primaquine and quinine (see section 4.4).
Maltese: Methaemoglobinaemia tista' tiġi aċċentwata f'pazjenti li diġà jkunu qed jieħdu prodotti mediċinali magħrufa li jinduċu l-kondizzjoni, eż. sulphonamides, acetanilid, żebgħa tal-aniline, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrati u nitriti, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, aċidu para-aminosalicylic, phenobarbital, phenytoin, primaquine u quinine(ara sezzjoni 4.4).
English: • a high temperature
Maltese: • temperatura għolja
English: • Glyceryl trinitrate (GTN, nitroglycerin), isosorbide mononitrate, erythrityl tetranitrate, pentaerythritol tetranitrate and other nitrate and nitrite medicines - used to treat angina (chest pain caused by the heart)
Maltese: • Glyceryl trinitrate (GTN, nitroglycerin), isosorbide mononitrate, erythrityl tetranitrate, pentaerythritol tetranitrate u mediċini oħra tan-nitrat u tan-nitrit li jintużaw biex tiġi ttrattata l-anġina (uġigħ fis-sider ikkawżat mill-qalb)
English: The clinically significant increases in IELT were paralleled by significant differences in the IPE scores (p < 0.0001).
Maltese: Iż-żidiet klinikament sinifikanti fl-IELT imxew b'mod parallel mad-differenzi sinifikanti fil-punteġġi IPE (p < 0.0001).
English: The terminal elimination half-life of lidocaine from the plasma following intravenous administration is approximately 65 - 150 minutes and the systemic clearance is 10 - 20 mL/min/kg.
Maltese: Il-half-life ta' eliminazzjoni terminali ta' lidocaine mill-plażma wara li ngħata ġol-vina hija ta' madwar 65 - 150 minuta u t-tneħħija sistemika hija ta' 10 - 20 mL/min/kg.
English: The lidocaine metabolite 2,6-xylidine has genotoxic potential in vitro.
Maltese: Il-metabolit ta' lidocaine 2,6-xylidine għandu potenzjal ġenotossiku in vitro.
English: Cutaneous spray, solution 6.5 ml
Maltese: U KONTENUT Sprej għall-ġilda, soluzzjoni 6.5 mL
English: Senstend may reduce the possibility of pregnancy, but is not a reliable contraceptive.
Maltese: Senstend jista' jnaqqas il-possibbiltà li tinqabad tqila, iżda mhuwiex kontraċettiv affidabbli.
English: WA7 1NU
Maltese: N01BB20
English: In vitro interaction studies with topical antifungal (clotrimazole, econazole, imidazole, nystatin, miconazole, ketoconazole), antibacterial (clindamycin, metronidazole) and antiviral medicinal products (acyclovir), showed no effect on antimicrobial activity.
Maltese: Fi studji ta' interazzjoni in vitro b'antifungali topiku (clotrimazole, econazole, imidazole, nystatin, miconazole, ketoconazole), il-prodotti mediċinali antibatteriċi (clindamycin, metronidazole) u antivirali (acyclovir), ma wrew l-ebda effett fuq l-attività antimikrobika.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Maltese: L-istudji fl-annimali ma jindikawx tossiċità riproduttiva (ara sezzjoni 5.3).
English: • abnormal orgasm
Maltese: • orgażmu anormali
English: The metabolism of lidocaine and prilocaine results in the formation of 2,6-xylidine and o-toluidine, respectively, amongst other metabolites.
Maltese: Il-metaboliżmu ta' lidocaine u prilocaine jwassal għall-formazzjoni ta' 2,6-xylidine u o-toluidine, rispettivament, fost metaboliti oħra.
English: During the 3 months of the double-blind treatment phase, the geometric mean IELT increased from 0.58 to 3.17 minutes in the Senstend group and from 0.56 to 0.94 minutes in the placebo group.
Maltese: Matul it-3 xhur tal-fażi ta' trattament double blind, il-medja ġeometrika tal-IELT żdiedet minn 0.58 sa 3.17 minuta fil-grupp ta' Senstend u minn 0.56 sa 0.94 minuta fil-grupp tal-plaċebo.
English: Local anaesthetic toxicity is manifested by symptoms of nervous system excitation and, in severe cases, central nervous and cardiovascular depression.
Maltese: It-tossiċità tal-anestetiku lokali hija mmanifestata mis-sintomi ta' eċċitazzjoni tas-sistema nervuża u, f'każijiet severi, depressjoni kardjovaskulari u tas-sistema nervuża ċentrali.
English: Also contains: norflurane
Maltese: TA' EĊĊIPJENTI Fih ukoll: norflurane
English: The elimination half-life of prilocaine following intravenous administration is approximately 10 - 150 minutes.
Maltese: Il-half-life ta' elimazzjoni ta' prilocaine wara l-għoti ġol-vina hija ta' madwar 10 - 150 minuta.
English: Senstend provides topical anaesthesia to the glans penis.
Maltese: Senstend jipprovdi anestesija topika għall-pene glans.
English: There is limited data on the efficacy and safety of Senstend in patients 65 years and over.
Maltese: Hemm data limitata dwar l-effikaċja u s-sigurtà ta' Senstend f'pazjenti li għandhom 65 sena jew aktar.
English: Senstend 150 mg/ml + 50 mg/ml cutaneous spray, solution lidocaine/prilocaine
Maltese: Senstend 150 mg/mL + 50 mg/mL sprej għall-ġilda, soluzzjoni lidocaine/prilocaine
English: Senstend 150 mg/ml + 50 mg/ml cutaneous spray, solution
Maltese: Senstend 150 mg/mL + 50 mg/mL sprejgħall-ġilda, soluzzjoni
English: Human exposure from Senstend is 20-30 fold less than the minimum dose that did not result in tumours and 200 fold less than the minimum dose that did result in tumours.
Maltese: L-esponiment tal-bniedem minn Senstend huwa 20-30 darba anqas mid-doża minima li ma tirriżultax f'tumuri u 200 darba anqas mid-doża minima li rriżultat f'tumuri.
English: Specific interaction studies with lidocaine/prilocaine and anti-arrhythmic medicinal products class III (e.g. amiodarone) have not been performed, but caution is advised (see also section 4.4).
Maltese: Ma twettqux studji ta' interazzjoni speċifiċi mal-prodotti mediċinali lidocaine/prilocaine u kontra l-arritmija tal-klassi III (eż. amiodarone), iżda hija rrakkomandata kawtela (ara wkoll sezzjoni 4.4).
English: Senstend is indicated for the treatment of primary premature ejaculation in adult men.
Maltese: Senstend huwa indikat għat-trattament ta' eġakulazzjoni prematura primarja fl-irġiel adulti.
English: • Sulphonamides (also called sulpha medicines) e.g. sulfamethoxazole - an antibiotic used to treat urinary infections, and sulfasalazine - used to treat Crohn's disease, ulcerative colitis and rheumatoid arthritis
Maltese: • Sulphonamides (imsejħa wkoll mediċini sulpha) eż. sulfamethoxazole - antibjotiku li jintuża biex jiġu ttrattati infezzjonijiet fis-sistema urinarja, u sulfasalazine - li jintuża biex jittratta l-marda ta' Crohn, il-kolite ulċerattiva u l-artrite idjopatika
English: 85.2% of subjects in the Senstend group achieved a mean IELT of > 1 minute over the course of 3 months of treatment with it, whereas 46.4% of the placebo subjects had a mean IELT of > 1 minute.
Maltese: 85.2% tas-suġġetti fil-grupp ta' Senstend laħqu medja ta' IELT ta' > minuta matul il-kors ta' 3 xhur ta' trattament bih, filwaqt li 46.4% tas-suġġetti tal-plaċebo kellhom medja ta' IELT ta' > minuta. 66.2% ta' Senstend tas-suġġetti ttrattati u 18.8% tas-suġġetti ttrattati bil-plaċebo laħqu medja ta' IELT > 2 minuti.
English: Anaemia related conditions
Maltese: Kondizzjonijiet relatati mal-anemija
English: Other medicines and Senstend
Maltese: Mediċini oħra u Senstend
English: Plethora Pharma Solutions Ltd. Puh/Tel: +44 (0)20 3077 5400
Maltese: Puh/Tel: +44 (0)20
English: Adjusted mean change scores (Senstend vs. placebo) at Month 3 were 8.2 vs. 2.2 for the ejaculatory control score, 7.2 vs. 1.9 for the sexual satisfaction score, and 3.7 vs. 1.1 for the distress score.
Maltese: 1.9 għall-punteġġ ta' sodisfazzjon sesswali, u 3.7 vs. 1.1 għall-punteġġ ta' skumdità.
English: Clinical trials have shown Senstend to increase the intra-vaginal ejaculatory latency time (IELT), increase control over ejaculation and reduce the feelings of distress in patients with premature ejaculation as measured by the Index of Premature Ejaculation (IPE).
Maltese: Provi kliniċi wrew li Senstend jżid l-ħin ta' latenza tal-eġakulazzjoni intra-vaġinali (IELT), iżid il-kontroll fuq l-eġakulazzjoni u jnaqqas is-sensazzjoni ta' skumdità f'pazjenti b'eġakulazzjoni prematura kif imkejjel mill-Indiċi tal-Eġakulazzjoni Prematura (IPE).
English: The risk of additional systemic toxicity should be considered when large doses of Senstend are applied to patients already using other local anaesthetics or structurally related medicinal products, e.g. class I anti-arrhythmics such as mexiletine.
Maltese: Ir-riskju ta' tossiċità sistemika addizzjonali għandu jiġi kkunsidrat meta dożi kbar ta' Senstend jiġu applikati lill-pazjenti li jkunu diġà qed jużaw anestetiċi lokali jew prodotti mediċinali oħra relatati strutturalment, eż. anti-arritmiċi tal-klassi I bħal mexiletine.
English: senstend
Maltese: Tqala
English: • Metoclopramide - used to treat feelings of sickness (nausea) and vomiting, including in patients with migraine
Maltese: • Metoclopramide - li jintuża biex jittratta sintomi ta' mard (dardir) u rimettar, inkluż f'pazjenti bl-emigranja
English: In an in vitro study of rats Senstend has shown a reduction in sperm motility when 22.5 mg lidocaine and 7.5 mg prilocaine (i.e. the amount in 1 human dose) was in direct contact with rat sperm.
Maltese: Fi studju in vitro tal-firien, Senstend wera tnaqqis fil-motilità tal-isperma meta 22.5 mg lidocaine u 7.5 mg prilocaine (jiġifieri l-ammont f'doża tal-bniedem waħda) kienu f'kuntatt dirett mal-isperma tal-firien.
English: Common Hypoaesthesia of male genital, erectile dysfunction, genital burning sensation
Maltese: Ipoesteżija tal-ġenitali tal-irġiel, disfunzjoni erettili, sensazzjoni ta' ħruq fil-ġenitali
English: If you use Senstend with condoms, you may be more likely to be unable to develop or maintain an erection.
Maltese: Jekk tuża Senstend mal-kondoms, huwa aktar probabbli li ma tkunx tista' tiżviluppa jew iżżomm erezzjoni.
English: Plethora Pharma Solutions Ltd. Tlf: +44 (0)20 3077 5400
Maltese: Tlf: +44 (0)20
English: Patients or their partner with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to medicinal product-induced methaemoglobinaemia (see section 4.5).
Maltese: Il-pazjenti jew is-sieħeb/sieħba tagħhom b'defiċjenza ta' glucose-6-phosphate dehydrogenase jew methaemoglobinaemia konġenitali jew idjopatika huma aktar suxxettibbli għall-methaemoglobinaemia indotta mill-prodotti mediċinali (ara sezzjoni 4.5).
English: Senstend is indicated for the treatment of lifelong premature ejaculation in adult men.
Maltese: Senstend huwa indikat għat-trattament ta' eġakulazzjoni prematura tul il-ħajja fl-irġiel adulti.
English: First pass metabolism is rapid and extensive and bioavailability is about 35% after oral doses.
Maltese: Il-metaboliżmu first pass huwa rapidu u estensiv filwaqt li l-bijodisponibbiltà hija madwar 35% wara d-dożi orali.
English: The efficacy of Senstend was demonstrated in two multi-centre, multinational, randomised, double-blind, placebo controlled studies, both followed by an open-label phase.
Maltese: L-effikaċja ta' Senstend ntweriet f'żewġ studji kkontrollati tal-plaċebo, double-blind, każwali, multinazzjonal, multiċentrali, li t-tnejn kienu segwiti minn fażi b'tikketta miftuħa.
English: Plethora Pharma Solutions Ltd. Tél: +44 (0)20 3077 5400
Maltese: Tél: +44 (0)20
English: Senstend is only indicated for application to the glans penis.
Maltese: Senstend huwa indikat biss għall-applikazzjoni fuq il-pene glans.
English: Plethora Pharma Solutions Ltd. Tél/Tel: +44 (0)20 3077 5400
Maltese: Tél/Tel: +44 (0)20
English: Lot
Maltese: U
English: Within each frequency grouping, adverse reactions are presented in order of decreasing incidence.
Maltese: Frekwenza Reazzjonijiet Avversi Infezzjonijiet u infestazzjonijiet Mhux Komuni
English: Common Vulvovaginal burning sensation, hypoaesthesia Uncommon Vulvovaginal discomfort, vaginal pain,
Maltese: Sensazzjoni ta' ħruq vulvovaġinali, ipoesteżija
English: • feeling of burning in and around the vagina • reduced feeling in and around the vagina
Maltese: • sensazzjoni ta' ħruq fil-vaġina u madwarha • sensazzjoni mnaqqsa fil-vaġina u madwarha
English: {MM/YYYY}
Maltese: L/kg.
English: Uncommon Pyrexia
Maltese: TA' KIF JINGĦATA
English: There is no relevant use of Senstend in the paediatric population for the indication of treatment of primary premature ejaculation in adult men.
Maltese: M'hemm l-ebda użu rilevanti ta' Senstend fil-popolazzjoni pedjatrika għall-indikazzjoni tat-trattament tal-eġakulazzjoni prematura primarja fl-irġiel adulti.
English: For all of the three monthly assessments completed by the subjects, there was a significant difference between Senstend and placebo (p < 0.0001).
Maltese: Kien hemm ukoll differenza sinifikanti mill-plaċebo fl-oqsma kollha għar-risponsi mis-sieħba (p < 0.0001).
English: Plethora Pharma Solutions Ltd. Τηλ: +44 (0)20 3077 5400
Maltese: Τηλ: +44 (0)20
English: Medicinal products subject to medical prescription
Maltese: IL-PRODOTT MEDIĊINALI
English: Talk to your doctor or pharmacist before using Senstend - if you, or your sexual partner, have been diagnosed with a genetic disease or other condition affecting your red blood cells (glucose-6-phosphate deficiency, anaemia or methaemoglobinaemia); - if you have a history of medicine sensitivities, especially if you are not certain which medicine causes sensitivity; - if you suffer from severe liver problems.
Maltese: anemija jew methaemoglobinaemia); - jekk għandek storja ta' sensittività għal mediċini, speċjalment jekk m'intix ċert liema mediċina tikkawża s-sensittività; - jekk issofri minn problemi severi fil-fwied.
English: Do not use this medicine after the expiry date which is stated on the spray container label and the carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq it-tikketta tal-kontenitur tal-isprej u l-kartuna wara “JIS”.
English: Due to the risk of partner transfer, patients hoping to achieve conception should either avoid using Senstend, or, if it is essential to achieve penetration, should wash the glans penis as thoroughly as possible 5 minutes after applying the spray but prior to intercourse (see section 4.6).
Maltese: Minħabba r-riskju ta' trasferiment għas-sieħba, il-pazjenti li jkunu qed jittamaw li jikkonċepixxu għandhom jevitaw li jużaw Senstend, jew, jekk ikun essenzjali li jkun hemm penetrazzjoni, għandhom jaħslu l-pene glans kemm jista' jkun bir-reqqa 5 minuti wara l-applikazzjoni tal-isprej iżda qabel l-att sesswali (ara sezzjoni 4.6).
English: The following side effects have been reported with Senstend in male patients:
Maltese: Dan huwa partikolarment importanti jekk tkun qed tieħu l-mediċini li ġejjin li jistgħu jinteraġġixxu ma' Senstend:
English: Senstend sprayed onto a damaged tympanic membrane may cause ototoxicity of the middle ear.
Maltese: Senstend sprejjat fuq membrana timpanika danneġġjata jista' jikkawża ototossiċità tal-widna tan-nofs.
English: Any barrier contraceptives (e.g. male or female condom), which are made from polyurethane-based material cannot be guaranteed to protect against disease or pregnancy when you are also using Senstend.
Maltese: Kwalunkwe kontraċettiv barriera (eż. kondom tal-irġiel jew tan-nisa) li huwa magħmul minn materjal ibbażat fuq il-polyurethane ma jistax jiggarantixxi li jipproteġi kontra mard jew tqala meta tkun qed tuża Senstend wkoll.
English: Although the systemic availability of prilocaine by cutaneous absorption of Senstend is low, caution should be exercised in patients with anaemia, congenital or acquired methaemoglobinaemia or patients on concomitant therapy known to produce such conditions.
Maltese: Għalkemm id-disponibbiltà sistemika ta' prilocaine mill-assorbiment fil-ġilda ta' Senstend hija baxxa, għandha tiġi eżerċitata kawtela f'pazjenti b'anemija, methaemoglobinaemia konġenitali jew miksuba, jew pazjenti li qed jieħdu terapija konkomitanti magħrufa li tipproduċi dawn il-kondizzjonijiet.
English: Deterioriation was observed when Senstend was used with polyurethane-based female and male condoms.
Maltese: Kienet osservata deterjorazzjoni meta Senstend ntuża ma' kondoms tal-irġiel u n-nisa magħmulin mill-polyurethane.
English: The effectiveness of Senstend in treating PE was assessed by measuring IELT and the co primary endpoints of ejaculatory control, sexual satisfaction, and distress using the IPE.
Maltese: L-effikaċja ta' Senstend fit-trattament tal-PE ġiet ivvaluta billi tkejjel IELT u l-punti finali ko-primarji ta' kontroll tal-eġakulazzjoni, sodisfazzjon sesswali, u skumdità minħabba l-użu tal-IPE.
English: Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine; however, Senstend should be used with caution in patients with a history (or partner with a history) of sensitivities to medicinal products, especially if the aetiologic medicinal product is uncertain.
Maltese: Il-pazjenti allerġiċi għad-derivattivi tal-aċidu paraaminobenzoic (procaine, tetracaine, benzocaine, eċċ) ma wrewx sensittività trasversali għal lidocaine u/jew prilocaine, madankollu, Senstend għandu jintuża b'kawtela f'pazjenti bi storja (jew sieħeb/sieħba bi storja) ta' sensittivitajiet għal prodotti mediċinali, speċjalment jekk il-prodott mediċinali etijoloġiku mhuwiex ċert.
English: Deterioriation was observed when Senstend was used with polyurethane-based female and male condoms (see section 4.4).
Maltese: Kienet osservata deterjorazzjoni meta Senstend ntuża ma' kondoms tal-irġiel u n-nisa magħmulin mill-polyurethane (ara sezzjoni 4.4).
English: vulvovaginal pruritus
Maltese: Kif taħżen Senstend
English: • Feeling light-headed or dizzy
Maltese: • diffikultà jew uġigħ waqt li tgħaddi l-awrina
English: Bevespi Aerosphere (glycopyrronium bromide / formoterol) EMA/752588/2018
Maltese: Aerosphere (glikopirronju bromur / formoterol) EMA/752588/2018
English: Further information on Bevespi Aerosphere can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Bevespi-Aerosphere.
Maltese: Aerosphere tinstab fis-sit elettroniku talAġenzija: ema.europa.eu/medicines/human/EPAR/Bevespi-Aerosphere.
English: Bevespi Aerosphere (glycopyrronium bromide / formoterol)
Maltese: Aerosphere (glikopirronju bromur / formoterol)
English: Formoterol is a long-acting beta-2 agonist.
Maltese: Il-formoterol huwa agonista ta' beta-2 li taħdem fit-tul.
English: Glycopyrronium bromide is a muscarinic receptor antagonist.
Maltese: Il-glikopirronju bromur huwa antagonista ta' riċettur muskariniku.
English: What are the risks associated with Bevespi Aerosphere?
Maltese: X'inhuma r-riskji assoċjati ma' Bevespi Aerosphere?
English: Bevespi Aerosphere is a medicine used in adults to relieve the symptoms of chronic obstructive pulmonary disease (COPD).
Maltese: Aerosphere huwa mediċina użata biex ittaffi s-sintomi tal-mard pulmonari ostruttiv kroniku (COPD) fl-adulti.
English: Other information about Bevespi Aerosphere
Maltese: Informazzjoni oħra dwar Bevespi
English: Bevespi Aerosphere is available as a liquid in a portable inhaler device.
Maltese: Aerosphere jiġi bħala likwidu f'apparat inalatur portabbli.
English: Side effects are considered mild to moderate in severity and are similar to other COPD medicines.
Maltese: L-effetti sekondarji huma kkunsidrati ħfief sa moderati fis-severità u huma simili għal mediċini oħra COPD.
English: In these studies, patients treated with Bevespi Aerosphere for 24 weeks had FEV1 increases of around 135 to 150 ml.
Maltese: Aerosphera għal 24 ġimgħa kellhom żidiet ta' FEV1 ta' madwar 135 sa 150 ml.
English: The most common side effects with Bevespi Aerosphere (which may affect up to 1 in 10 people) include headache, nausea (feeling sick), muscle spasms and dizziness.
Maltese: L-effetti sekondarji l-aktar komuni b'Bevespi Aerosphere (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma wġigħ ta' ras, nawżja (tħossok ma tiflaħx), spażmi tal-muskoli u sturdament.
English: The studies also showed that Bevespi Aerosphere improved FEV1 more than the single components in the medicine.
Maltese: Aerosphera tejjeb il-FEV1 aktar mill-komponenti uniċi fil-mediċina.
English: It contains the active substances glycopyrronium bromide and formoterol.
Maltese: Fih is-sustanzi attivi glikopirronju bromur u formoterol.
English: Patients who received placebo (a dummy treatment), on the other hand, had increases of up to 8 ml or reductions of up to 20 ml.
Maltese: Mill-banda l-oħra, il-pazjenti li ngħataw il-plaċebo (kura finta) kellhom żidiet sa 8 ml jew tnaqqis sa 20 ml.
English: Side effects reported with Bevespi Aerosphere are carefully evaluated and any necessary action taken to protect patients.
Maltese: Aerosphere huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.