FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency not known - Ovarian macrocysts (with symptoms such as pelvic pain, bleeding) - Decreased androstenedione (precursor of sex hormones) in blood tests in females - Decreased testosterone (sex hormone) in blood tests in females - Sex hormone binding globulin (a protein which binds sex hormones) increased in blood tests - Decreased free testosterone (sex hormone) in blood tests in males
Maltese: Frekwenza mhux magħrufa - Makroċesti ovarji (b'sintomi bħal uġigħ pelviku, tnixxija ta' demm) - Androstenedjon imnaqqas (prekursur tal-ormoni sesswali) f'testijiet tad-demm fin-nisa - Testosteron imnaqqas (ormon sesswali) f'testijiet tad-demm fin-nisa - Globulina li tgħaqqad l-ormon sesswali (proteina li tgħaqqad l-ormoni tas-sess) żdiedet fit-testijiet tad-demm - Testosteron ħieles imnaqqas (ormon sesswali) f'testijiet tad-demm fl-irġiel
English: Carriers of HBV who require treatment with BRANDNAME DRUG should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Maltese: TAL-MEDIĊINA għandhom jiġu mmonitorjati mill-qrib għal sinjali u għal sintomi tal-infezzjoni attiva tal-HBV waqt il-kura u għal diversi xhur wara li tintemm il-kura (ara sezzjoni 4.8).
English: Isolated cases of complicated cysts have been reported (adnexal torsion and haemorrhagic cyst rupture).
Maltese: SOC: Investigazzjonijiet (frekwenza mhux magħrufa):
English: Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Maltese: L-esperti fil-mard tal-fwied u fil-kura tal-epatite B għandhom jiġu kkonsultati qabel ma tibda l-kura f'pazjenti b'seroloġija pożittiva tal-epatite B (inklużi dawk bil-marda attiva) u għal dawk il-pazjenti li nstabu pożittivi għall-infezzjoni tal-HBV matul il-kura.
English: Description of selected adverse reactions:
Maltese: Frekwenza 'mhux magħrufa':
English: 4.8 Undesirable effects SOC: Investigations (frequency not known): - Blood androstenedione decreased (in females) - Blood testosterone decreased (in females) - Sex hormone binding globulin increased - Blood free testosterone decreased (in males) SOC: Reproductive system and breast disorders (frequency not known): - Ovarian macrocysts Premenopausal women: non-malignant ovarian macrocysts (with symptoms such as pelvic pain, bleeding) have been described.
Maltese: - Androstenedjon tad-demm imnaqqas (fin-nisa) - Testosteron tad-demm imnaqqas (fin-nisa) - Globulina li tgħaqqad l-ormon sesswali żdiedet - Testosteron ħieles tad-demm naqas (fl-irġiel)
English: • Blockage (obstruction), bleeding or ulcer in the gut.
Maltese: • Imblokk (imblukkar), tnixxija tad-demm jew ulċera fl-imsaren.
English: • Sliding of one part of the gut into an adjacent part of the gut (intussusception)
Maltese: • Iż-żerżieqa ta' parti waħda mill-imsaren f'parti biswit l-imsaren (intussuxezzjoni)
English: This is because BRANDNAME DRUG could cause hepatitis B to become active again, which can be fatal in some cases.
Maltese: TAL-MEDIĊINA jista' jwassal sabiex epatite B jerġa' jiġi attiv, u f'xi każijiet dan jista' jkun fatali.
English: New product information wording - Extracts from PRAC recommendations on signals
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: 11 April 2012 EMA/CHMP/763180/2011 Corr to Rev 1
Maltese: 11 ta' April 2012 EMA/CHMP/763180/2011 Korr għal Rev 1
English: They include camphor, cineole, terpineol, terpine, citral and menthol.
Maltese: Fosthom insibu l-kanfora, il-kineolu, it-terpineolu, it-terpina, iċ-ċitralu u l-mentolu.
English: What are suppositories containing terpenic derivatives?
Maltese: X'inhuma s-suppożitorji li fihom id-derivati terpeniċi?
English: Questions and answers on the review of suppositories containing terpenic derivatives EMA/CHMP/763180/2011 Corr to Rev 1
Maltese: EMA/CHMP/763180/2011 Korr∗ għal Rev 1
English: It also decided that there was a risk of these medicines causing local anorectal lesions.
Maltese: Iddeċieda wkoll li kien hemm ir-riskju li dawn il-mediċini jikkawżaw leżjonijiet anorettali lokali.
English: They are currently marketed in Belgium, France, Luxembourg, Finland, Italy, Portugal and Spain under various trade names.
Maltese: Bħalissa jinsabu fis-suq b'diversi ismijiet kummerċjali f'dawn il-pajjiżi: il-Belġju, Franza, il-Lussemburgu, il-Finlandja, l-Italja, il-Portugall u Spanja.
English: They are also found in essential oils obtained from plants, such as niaouli, wild thyme or eucalyptus.
Maltese: Jinstabu wkoll fi żjut essenzjali misluta mill-pjanti, bħan-njawli, is-sagħtar salvaġġ u l-ewkaliptu.
English: The approved indications vary in different EU countries, but typically include supportive treatment for mild, sudden bronchial disorders, particularly productive and non-productive cough.
Maltese: L-indikazzjonijiet approvati fl-UE jvarjaw minn pajjiż għal ieħor, iżda ġeneralment jinkludu trattament ta' appoġġ għal disturbi bronkjali moderati u għal għarrieda, b'mod partikulari s-sogħla produttiva u s-sogħla mhux produttiva.
English: They are often found in herbal substances and herbal preparations, such as pine needle or turpentine.
Maltese: Jinsabu spiss f'sustanzi erbali u fi preparati veġetali, bħall-weraq tal-arżnu u t-turpentina.
English: This included study data supporting the marketing authorisations and safety data including reports of side effects from post-marketing surveillance and the published literature.
Maltese: Dan kollu inkluda dejta li tiġġustifika l-awtorizzazzjonijiet għat-tqegħid fis-suq u dejta rigward is-sikurezza li tinkludi rapporti dwar l-effetti sekondarji li ħarġu minn sorveljanzi li saru wara t-tqegħid fis-suq kif ukoll iddokumentazzjoni ppubblikata.
English:  Editorial revisions have been made in the description of terpenic derivatives to ensure accuracy.
Maltese: ∗ Saru reviżjonijiet fid-deskrizzjoni ta' derivati terpeniċi sabiex tiġi aċċertata l-eżattezza.
English: The French medicines regulatory agency had concerns about the safety of suppositories containing terpenic derivatives, particularly the risk of serious neurological side effects in young children such as
Maltese: L-awtorità regolatorja Franċiża tal-mediċini kienet imħassba dwar is-sikurezza tas-suppożitorji li fihom id-derivati terpeniċi, b'mod partikulari dwar ir-riskju li jiżviluppaw effetti newroloġiċi serji fi tfal żgħar bħall-konvulżjonijiet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the use of these medicines should be contraindicated in children under 30 months old, children with a history of epilepsy or febrile convulsion and children with a recent history of anorectal lesion (precancerous growths in the anus or rectum).
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-użu ta' dawn il-mediċini għandu jkun kontraindikat fi tfal ta' taħt it-30 xahar, fi tfal bi storja ta' konvulżjonijiet epilettiki jew febbrili u fi tfal bi storja riċenti ta' leżjoni anorettali (tkabbir prekarju fl-anus jew fir-rektum).
English: • Suppositories containing terpenic derivatives should not be used in children under 30 months old, children with a history of epilepsy or febrile convulsion and children with a recent history of anorectal lesion.
Maltese: • Is-suppożitorji li fihom id-derivati terpeniċi ma għandhomx jintużaw fuq tfal iżgħar minn 30 xahar, fuq tfal bi storja ta' konvulżjonijiet epilettiki jew febbrili u fuq tfal bi storja riċenti ta' leżjoni anorettali.
English: Suppositories containing terpenic derivatives are medicines given rectally used to treat various conditions.
Maltese: Is-suppożitorji li fihom id-derivati terpeniċi huma mediċini li jingħataw b'mod rettali biex jikkuraw diversi kundizzjoniiet.
English: The CHMP looked at the benefit-risk assessment carried out by France, and information requested from the companies that market suppositories containing terpenic derivatives in the EU.
Maltese: Is-CHMP eżamina l-valutazzjoni benefiċċju-riskju li saret fi Franza u l-informazzjoni mitluba millkumpaniji li jpoġġu fis-suq tal-UE s-suppożitorji li fihom id-derivati terpeniċi.
English: Terpenic derivatives are mainly obtained from natural substances originating from plants such as conifers.
Maltese: Id-derivati terpeniċi jinsiltu l-iżjed minn sustanzi naturali li joriġinaw minn pjanti bħall-koniferi.
English: Consequently, on 27 October 2010 the French agency asked the CHMP to carry out a full assessment of the benefit-risk balance of suppositories containing terpenic derivatives in children younger than 30 months of age and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU in this population.
Maltese: Għaldaqstant, fis-27 ta' Ottubru 2010 l-aġenzija Franċiża talbet lis-CHMP jagħmel valutazzjoni sħiħa tal-bilanċ benefiċċju-riskju tal-użu tas-suppożitorji li fihom id-derivati terpeniċi fuq tfal iżgħar minn 30 xahar.
English: The French agency was also concerned that reliable data on the effectiveness of these medicines were not available, and that the medicines did not fulfil the latest clinical recommendations for treating cough in children.
Maltese: L-aġenzija Franċiża kienet imħassba wkoll li ma kienx hemm dejta affidabbli rigward l-effikaċja ta' dawn il-mediċini, u li l-mediċini inkwistjoni ma jissodisfawx l-iżjed rakkomandazzjonijiet kliniċi reċenti dwar il-kura tas-sogħla fit-tfal.
English: Why were suppositories containing terpenic derivatives reviewed?
Maltese: Għaliex is-suppożitorji li fihom id-derivati terpeniċi ġew riveduti?
English: The CHMP noted that children aged up to 30 months and children with a history of epilepsy or febrile convulsion were most at risk of these neurological side effects because their nervous system is not yet fully developed.
Maltese: Is-CHMP irrimarka li tfal iżgħar minn 30 xahar u tfal bi storja ta' konvulżjonijiet epilettiki jew febbrili kienu l-iżjed vulnerabbli għal dawn l-effetti sekondarji newroloġiċi, minħabba li s-sistema nervuża tagħhom ma tkunx għadha żviluppat bis-sħiħ.
English: The Committee therefore recommended that the use of suppositories containing terpenic derivatives be contraindicated in children under 30 months old, children with a history of epilepsy or febrile convulsion and children with a recent history of anorectal lesion.
Maltese: Għaldaqstant il-Kumitat irrakkomanda l-kontaindikazzjoni tal-użu tas-suppożitorji li fihom id-derivati terpeniċi fuq tfal iżgħar minn 30 xahar, fuq tfal bi storja ta' konvulżjonijiet epilettiki jew febbrili u fuq tfal bi storja riċenti ta' leżjoni anorettali.
English: The European Medicines Agency has completed a review of the safety and effectiveness of suppositories containing terpenic derivatives.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni dwar is-sikurezza u l-effikaċja ta' suppożitorji li fihom id-derivati terpeniċi.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that there was a risk of these medicines inducing neurological disorders, especially convulsions, in infants and small children.
Maltese: Abbażi tal-valutazzjoni tad-dejta disponibbli bħalissa u tad-diskussjoni xjentifika li saret fil-Kumitat, isCHMP ikkonkluda li hemm riskju li dawn il-mediċini jikkaġunaw ċerti disturbi newroloġiċi, b'mod speċjali konvulżjonijiet, fit-trabi u fit-tfal żgħar.
English: The full EPAR 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: How is the medicine used?
Maltese: din il mediċina?
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva huwa mediċina li tintuża fil-kura ta' adulti li jkunu infettati bil-virus tal-immunodefiċjenza umana-1 (HIV-1), virus li jikkawża s-sindrome millimmunodefiċjenza akkwiżita (AIDS, acquired immune deficiency syndrome).
English: This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Maltese: Din il-mediċina fiha tliet sustanzi attivi: l-efavirenz, li hija inibitur mhux nukleosidiku tat-transkrittażi inversa (NNRTI, non-nucleoside reverse transcriptase inhibitor); l-emtriċitabina, li hija inibitur nukleosidiku tat-transkrittażi inversa; u t-tenofovir disoprossil, li hija “prodroga” tat-tenofovir, jiġifieri li tinbidel fis-sustanza attiva tenofovir fil-ġisem.
English: Efavirenz / emtricitabine / tenofovir disoproxil
Maltese: Efavirenz / emtriċitabina / tenofovir disoprossil
English: This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
English: The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with tenofovir disoproxil-containing medicines such as this one.
Maltese: Il-kumpanija li tqiegħed il-mediċina fis-suq se tiżgura li t-tobba kollha li mistennija li jippreskrivu lmedi ċina jiġu pprovduti b pakkett edukattiv li jinkludi informazzjoni dwar ir-riskju miżjud ta' mard filkliewi b' mediċini li fihom tenofovir disoprossil bħal din.
English: Because Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva huwa mediċina ġenerika u huwa bijoekwivalenti għall-medi ċina ta referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-medi ċina ta referenza.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat bil-medi ċina ta referenza, Atripla, u m' għandhomx għalfejn jiġu ripetuti għal Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
English: The educational pack also contains recommendations for monitoring kidney function in patients taking the medicine.
Maltese: Il-pakkett edukattiv fih ukoll rakkomandazzjonijiet għall-monitoraġġ tal-funzjoni tal-kliewi f' pazjenti li jkunu qed jieħdu l-mediċina.
English: All three active substances block the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Maltese: It-tliet sustanzi attivi kollha jimblukkaw l-attività tat-transkrittażi inversa, enzima prodotta mill-HIV li tħalliha tipproduċi lilha nnifisha fiċ-ċelluli li tkun infettat.
English: Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Maltese: Kemm inibituri nukleosidi kif ukoll nukleotidiċi tat-transkrittażi inversa huma magħrufa b' mod komuni bħala NRTIs.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva keeps the amount of HIV in the blood at a low level.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva jżomm l-ammont ta' HIV fid-demm f' livell baxx.
English: D-90429 Nuremberg Germany
Maltese: D-90429 Nürnberg Il-Ġermanja
English: In vitro inhibition studies demonstrated that glycopyrronium bromide has no relevant capacity to inhibit CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4/5, the efflux transporters MDR1, MRP2 or MXR, and the uptake transporters OCT1 or OCT2.
Maltese: Studji in vitro dwar l-inibizzjoni wrew li glycopyrronium bromide m'għandux kapaċità relevanti li jinibixxi CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 jew CYP3A4/5, ittrasportaturi tal-effluss MDR1, MRP2 or MXR, u t-trasportaturi tal-uptake OCT1 jew OCT2.
English: 6 x 1 capsules + 1 inhaler 10 x 1 capsules + 1 inhaler 12 x 1 capsules + 1 inhaler 30 x 1 capsules + 1 inhaler
Maltese: 6 x 1 kapsuli + inhaler wieħed 10 x 1 kapsuli + inhaler wieħed 12 x 1 kapsula + inhaler wieħed 30 x 1 kapsula + inhaler wieħed
English: • Throat irritation
Maltese: • Griżmejn irritati
English: Also contains: lactose and magnesium stearate.
Maltese: Fih ukoll: lactose and magnesium stearate.
English: In the pooled 6-month database the frequency of dry mouth was 2.2% versus 1.1%, of insomnia 1.0% versus 0.8%, and of gastroenteritis 1.4% versus 0.9%, for Tovanor Breezhaler and placebo respectively.
Maltese: Fid-databażi miġbura tul is-6 xahar il-frekwenza ta' ħalq xott kienet ta' 2.2% kontra 1.1%, ta' nuqqas ta' rqad 1.0% kontra 0.8%, u ta' gastroenterite 1.4% kontra 0.9%, għal Tovanor Breezhaler u plaċebo rispettivament.
English: Paradoxical bronchospasm
Maltese: Bronkospażmu paradossali2)
English: Each capsule contains 50 micrograms glycopyrronium.
Maltese: Kull kapsula fiha 50 mikrogramma glycopyrronium.
English: Excipient(s) with known effect: Each capsule contains 23.6 mg lactose (as monohydrate).
Maltese: Kull kapsula fiha 23.6 mg lactose (bħala monohydrate).
English: Alfasigma S.p.A. Tel: +39 06 91 39 4666
Maltese: Tel: +39 06 91 39 4666
English: Tovanor Breezhaler 44 micrograms once daily provided consistently statistically significant improvement in lung function (forced expiratory volume in one second, FEV1, forced vital capacity, FVC, and inspiratory capacity, IC) in a number of clinical studies.
Maltese: 44 mikrogramma Tovanor Breezhaler darba kuljum ipprovdew titjib statistikament sinifikanti konsistenti fil-funzjoni tal-pulmun (volum espiratorju sfurzat f'sekonda waħda, FEV1, kapaċità vitali sfurzata, FVC, u kapaċità ispiratorja, IC) f'għadd ta' studji kliniċi.
English: Secondary pharmacodynamic effects
Maltese: Effetti farmakodinamiċi sekondarji
English: Musculoskeletal and connective tissue disorders Musculoskeletal pain
Maltese: Disturbi muskoluskelettriċi u tat-tessuti konnettivi Uġigħ muskoluskeletriku
English: • Musculoskeletal pain
Maltese: • Uġigħ muskoluskeletriku
English: The steady-state mean peak and trough plasma concentrations of glycopyrronium for a 44 micrograms once-daily dosing regimen were 166 picograms/ml and 8 picograms/ml, respectively.
Maltese: Il-quċċata medja milħuqa waqt stat stabbli u permezz tal-konċentrazzjonijiet tal-plażma ta' glycopyrronium b'doża waħda ta' 44 mikrogramma kuljum kienet ta' 166 pikogramm/ml u 8 pikogrammi/ml rispettivament.
English: In addition, the corresponding frequency category for each adverse reaction is based on 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).
Maltese: Barra minn hekk, il-kategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa tissejjes fuq ilkonvenzjoni li ġejja: 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).
English: This medicine contains an active substance called glycopyrronium bromide.
Maltese: Din il-mediċina fiha sustanza attiva msejħa glycopyrronium bromide.
English: Cardiac disorders Atrial fibrillation
Maltese: Disturbi fil-qalb Fibrillazzjoni atrijali
English: Metabolism and nutrition disorders Hyperglycaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Ipergliċemija
English: In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Tovanor Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Tovanor Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
Maltese: Fl-istudju ta' 6 xhur, ilpersentaġġ ta' pazjenti li kellhom taħrix moderat jew sever kien ta' 17.5% għal Tovanor Breezhaler u ta' 24.2% għall-plaċebo (Proporzjon ta' periklu: 0.69, p=0.023), u fl-istudju ta' 12-il xahar kien ta' 32.8% għal Tovanor Breezhaler u ta' 40.2% għall-plaċebo (Proporzjon ta' periklu: 0.66, p=0.001).
English: Breezhaler inhaler).
Maltese: Breezhaler).
English: Tovanor Breezhaler 44 mcg inhalation powder glycopyrronium
Maltese: Tovanor Breezhaler 44 μg trab li jittieħed man-nifs glycopyrronium
English: In vitro enzyme induction studies did not indicate a clinically relevant induction by glycopyrronium bromide for cytochrome P450 isoenzymes, or for UGT1A1 and the transporters MDR1 and MRP2.
Maltese: Studji in vitro dwar l-induzzjoni tal-enzimi ma indikawx induzzjoni klinikament relevanti b'glycopyrronium bromide għaċ-ċitokromu tal-iżoenzimi P450, jew għal UGT1A1 u t-trasportaturi MDR1 u MRP2.
English: Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (44 micrograms once daily) of Tovanor Breezhaler and were well tolerated.
Maltese: L-ogħla livelli tal-plażma u l-espożizzjoni sistemika totali wara l-għoti ta' 150 mikrogramma glycopyrronimum bromide fil-vini (ekwivalenti għal 120 mikrogramma glycopyrronium) f'voluntiera b'saħħithom kienu ta' madwar 50 darba u 6 darbiet aktar mill-ogħla espożizzjoni u mill-espożizzjoni sħiħa fi stat fiss rispettivament miksuba mid-doża rrakkomandata (44 mikrogramma darba kuljum) ta' Tovanor Breezhaler u kienu ttollerati sew.
English: Tovanor Breezhaler administered at 44 micrograms once daily statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI).
Maltese: Tovanor Breezhaler mogħti f'doża ta' 44 mikrogramma kuljum inaqqas b'mod statistikament sinifikanti l-episodji ta' qtugħ ta' nifs skont kif evalwat mill-Indiċi ta' Dispnea Tranżitorja (TDI).
English: Hydroxylation resulting in a variety of mono-and bis-hydroxylated metabolites and direct hydrolysis resulting in the formation of a carboxylic acid derivative (M9) were seen.
Maltese: Kien hemm idroksillazzjoni li wasslet għal varjetà ta' metaboliti mono u bisidroksillati u idrolisi diretta li wasslet biex jiffurmaw derivattivi ta' aċdi karboksilliċi (M9).
English: Respiratory, thoracic and mediastinal disorders Sinus congestion
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Konġestjoni tas-sinus
English: In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) Tovanor Breezhaler can be used at the recommended dose.
Maltese: F'pazjenti b'COPD b'indeboliment tal-kliewi minn ħafif għal moderat (rata ta' filtrazzjoni glomerulari, eGFR taħt it-30 ml/min/1.73 m2) Tovanor Breezhaler jista' jintuża skont id-doża rrakkomandata.
English: Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules glycopyrronium (as glycopyrronium bromide)
Maltese: Tovanor Breezhaler 44 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa glycopyrronium (bħala glycopyrronium bromide)