FrancophonIA/ELRC3.0 huggingface dataset:
English: Lung volumes, exercise endurance and physical activity The effect of Duaklir Genuair on lung volumes, exercise endurance and physical activity was investigated in an 8-week parallel, randomised, placebo-controlled clinical study in COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Maltese: Volumi fil-pulmun, felħan għall-eżerċizzju u attività fiżika L-effett ta' Duaklir Genuair fuq il-volumi fil-pulmun, felħan għall-eżerċizzju u attività fiżika ġie investigat fi studju kliniku ta' 8 ġimgħat, parallel, randomizzat, ikkontrollat bil-plaċebo f'pazjenti b'COPD b'iperinflazzjoni (kapaċità residwali funzjonali
English: FEV1 at 1 hour post-dose and trough FEV1 (compared to aclidinium 400 micrograms and formoterol 12 micrograms, respectively) were defined as co-primary endpoints in both 6-month pivotal Phase III studies to demonstrate the bronchodilator contributions of formoterol and aclidinium in Duaklir Genuair, respectively.
Maltese: FEV1 f'siegħa wara d-doża u permezz ta' FEV1 (meta mqabbel ma' aclidinium 400 mikrogramma u formoterol 12 -il mikrogramma, rispettivament) kienu definiti bħala punti ta' tmiem koprimarji fiż-żewġ studji importanti ħafna ta' 6 xhur ta' Fażi
English: Following inhalation of Duaklir Genuair 340/12 micrograms, with plasma sampling up to 24 hours post-dose, the terminal elimination half-life observed for aclidinium bromide ranged from 11-33 hours and for formoterol from 12-18 hours.
Maltese: Wara t-teħid man-nifs ta' Duaklir Genuair 340/12-il mikrogramma, b'kampjun tal-plażma sa 24 siegħa wara d-doża, il-half life ta' eliminazzjoni terminali osservata għal aclidinium bromide varjat minn 11il siegħa sa 33 siegħa u għal formoterol minn 12-il siegħa sa 18-il siegħa.
English: Other medicines and Duaklir Genuair
Maltese: Mediċini oħra u Duaklir Genuair
English: In study ACLIFORM-COPD, Duaklir Genuair showed improvements in FEV1 at 1 hour post-dose relative to placebo and aclidinium of 299 ml and 125 ml, respectively (both p<0.0001) and improvements in trough FEV1 relative to placebo and formoterol of 143 ml and 85 ml, respectively (both p<0.0001).
Maltese: Fi studju ACLIFORM-COPD, Duaklir Genuair wera titjib f'FEV1 f'siegħa wara d-doża meta mqabbel ma' plaċebo u aclidinium ta' 299 ml u 125 ml, rispettivament (it-tnejn p<0.0001) u titjib fl-FEV1 l-aktar baxx meta mqabbel ma' plaċebo u formoterol ta' 143 ml u 85 ml, rispettivament (it-tnejn p<0.0001).
English: The peak plasma concentrations at steady state of aclidinium and formoterol observed in patients with COPD treated with Duaklir Genuair twice daily for 5 days were reached within 5 minutes post-inhalation and were 128 pg/ml and 17 pg/ml, respectively.
Maltese: L-ogħla konċetrazzjonijiet fil-plażma fi stat fiss ta' aclidinium u formoterol osservati fil-pazjenti b'COPD ikkurati b'Duaklir Genuair darbtejn kuljum għal 5 ijiem intlaħqu fi żmien 5 minuti wara l-inalazzjoni u kienu 128 pg/ml u 17 pg/ml, rispettivament.
English: No clinically significant effects of Duaklir Genuair on cardiac rhythm were observed on 24-hour Holter monitoring in a subset of 551 patients, of whom 114 received Duaklir Genuair twice daily.
Maltese: Ma ġie osservat l-ebda effett klinikament sinifikanti ta' Duaklir Genuair fuq ir-ritmu kardijaku matul monitoraġġ Holter ta' 24 siegħa f'sottosett ta' 551 pazjent, li 114 minnhom ingħataw Duaklir Genuair darbtejn kuljum.
English: - The other ingredient is lactose monohydrate (see end of section 2 under ‘Duaklir Genuair contains lactose' for more information).
Maltese: - Is-sustanza l-oħra hija lactose monohydrate (ara t-tmiem tas-sezzjoni 2 taħt “Duaklir Genuair fih lactose” għal aktar informazzjoni).
English: Duaklir Genuair should be administered with caution to patients being treated with medicinal products known to prolong the QTc interval such as monoamine oxidase inhibitors, tricyclic antidepressants, antihistamines or macrolides because the action of formoterol, a component of Duaklir Genuair, on the cardiovascular system may be potentiated by these medicinal products.
Maltese: Duaklir Genuair għandu jingħata b'kawtela lil pazjenti kkurati bi prodotti mediċinali magħrufin li jtawlu l-intervall QTc bħall-inibituri monoamine oxidase, l-antidepressanti triċikliċi, l-antistamini jew il-makrolidi peress li l-azzjoni ta' formoterol, komponent ta' Duaklir Genuair, fuq is-sistema kardjovaskulari tista' titqawwa minn dawn il-prodotti mediċinali.
English: Duaklir Genuair is not indicated for the treatment of acute episodes of bronchospasm.
Maltese: Duaklir Genuair mhuwiex indikat għat-trattament ta' episodji akuti ta' bronkospażmu.
English: Duaklir Genuair reduced the use of rescue medication over 6 months compared to placebo (by 0.9 puffs per day [p<0.0001]), aclidinium (by 0.4 puffs/day [p<0.001]) and formoterol (by 0.2 puffs/day [p=0.062]).
Maltese: Duaklir Genuair naqqas l-użu ta' medikazzjoni ta' salvataġġ matul 6 xhur meta mqabbel ma' plaċebo (b'0.9 għafsiet kuljum [p<0.0001]), aclidinium (b'0.4 għafsiet/kuljum [p<0.001]) u formoterol (b'0.2 għafsiet/kuljum [p=0.062]).
English: Duaklir Genuair 340/12 micrograms twice daily consistently provided clinically meaningful improvements in lung function (as assessed by FEV1, forced vital capacity and inspiratory capacity) compared with placebo.
Maltese: Duaklir Genuair 340/12-il mikrogramma darbtejn kuljum ipprovda b'mod konsistenti titjib sinifikanti fil-funzjoni tal-pulmuni (kif ivvalutat minn FEV1, kapaċità vitali sfurzata u kapaċità ispiratorja) meta mqabbel ma' plaċebo.
English: Duaklir Genuair 340 micrograms/12 micrograms inhalation powder aclidinium/formoterol fumarate dihydrate
Maltese: Duaklir Genuair 340 mikrogramma/12-il mikrogramma trab li jittieħed man-nifs aclidinium/formoterol fumarate dihydrate
English: In Phase III clinical studies, the frequency of notable increases in blood glucose with Duaklir Genuair was low (0.1%) and similar to placebo.
Maltese: III, il-frekwenza ta' żidiet notevoli fil-glukożju fid-demm b'Duaklir Genuair kienet baxxa (0.1%) u simili għal plaċebo.
English: Improvements in the PROactive total score were observed in patients treated with Duaklir Genuair compared with placebo (p=0.0002).
Maltese: Ġie osservat titjib fil-punteġġ totali PROactive f'pazjenti kkurati b'Duaklir Genuair meta mqabbel mal-plaċebo (p=0.0002).
English: The percentage of patients in AUGMENT who achieved a clinically meaningful improvement from baseline in SGRQ total score (defined as a decrease of at least 4 units) was higher with Duaklir Genuair than with placebo (58.2% compared to 38.7%, respectively; p<0.001).
Maltese: Il-perċentwal ta' pazjenti f'AUGMENT li kisbu titjib klinikament sinifikanti mil-linja bażi fil-punteġġ totali ta' SGRQ (definit bħala tnaqqis ta' mill-inqas 4 unitajiet) kien ogħla b'Duaklir Genuair milli bi plaċebo (58.2% meta mqabbel ma' 38.7%, rispettivament; p<0.001).
English: Duaklir Genuair improved daily symptoms of COPD such as ‘breathlessness', ‘chest symptoms', ‘cough and sputum' (assessed by E-RS total score) as well as overall night-time symptoms, overall early morning symptoms and symptoms limiting early morning activities compared to placebo, aclidinium and formoterol but the improvements were not always statistically significant.
Maltese: Duaklir Genuair tejjeb is-sintomi ta' kuljum ta' COPD bħal ‘qtugħ ta' nifs', ‘sintomi tas-sider', ‘sogħla u sputum' (ivvalutati bil-punteġġ totali ta' E-RS) kif ukoll sintomi ġenerali ta' matul il-lejl, is-sintomi ġenerali ta' kmieni filgħodu u sintomi li jillimitaw l-attivitajiet ta' filgħodu kmieni meta mqabbel ma' plaċebo, aclidinium u formoterol, iżda t-titjib ma kienx dejjem statistikament sinifikanti.
English: The percentages of patients with clinically meaningful improvements in TDI focal score (defined as an increase of at least 1 unit) were higher with Duaklir Genuair than with placebo in ACLIFORM-COPD (64.8% compared to 45.5%; p<0.001) and AUGMENT (58.1% compared to 36.6%; p<0.0001).
Maltese: Il-perċentwali tal-pazjent b'titjib klinikament li jagħmel sens fil-punteġġ fokali tat-TDI (definiti bħala żieda ta' mill-inqas unità waħda) kienu ogħla b'Duaklir Genuair milli bi plaċebo ACLIFORM-COPD (64.8% meta mqabbel ma' 45.5%; p<0.001) u AUGMENT (58.1% meta mqabbel ma' 36.6%; p<0.0001).
English: The onset of action of Duaklir Genuair was comparable to the effect of the fastacting β2-agonist formoterol 12 micrograms.
Maltese: Il-bidu ta' azzjoni ta' Duaklir Genuair kien komparabbli mal-effett tal-agonist β2 b'azzjoni rapida formoterol 12-il mikrogramma.
English: Hepatic impairment No dose adjustments are required in patients with hepatic impairment (see section 5.2).
Maltese: Indeboliment epatiku Ma huwa meħtieġ l-ebda aġġustament tad-doża fil-pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: Show the packaging of Duaklir Genuair.
Maltese: Uri l-pakkett ta' Duaklir Genuair.
English: In study ACLIFORM-COPD, only a small decrease in SGRQ total score compared to placebo was observed due to an unexpectedly large placebo response (p=0.598) and the percentages of patients who achieved clinically meaningful improvements from baseline were 55.3% with Duaklir Genuair and 53.2% with placebo (p=0.669).
Maltese: Fl-istudju ACLIFORM-COPD, ġie osservat biss tnaqqis żgħir fil-punteġġ totali tal-SGRQ meta mqabbel ma' plaċebo minħabba rispons kbir mhux mistenni bi plaċebo (p=0.598) u l-perċentwali ta' pazjenti li kisbu titjib klinikament sinifikanti mil-linja bażi kienu 55.3% bi Duaklir Genuair u 53.2% bi plaċebo (p=0.669)
English: Duaklir Genuair provided a clinically meaningful improvement in breathlessness (assessed by the Transition Dyspnoea Index [TDI]) with an improvement in the TDI focal score at 6 months compared to placebo of 1.29 units in study ACLIFORM-COPD (p<0.0001) and 1.44 units in study AUGMENT (p<0.0001).
Maltese: [TDI]) b'titjib fil-punteġġ fokali ta' TDI wara 6 xhur meta mqabbel ma' plaċebo ta' 1.29 unità fl-istudju ACLIFORM-COPD (p<0.0001) u 1.44 unità fl-istudju AUGMENT (p<0.0001).
English: Uncommon - Fast heart beat (tachycardia) - Chest pain or tightness in the chest (angina pectoris) - Blurred vision - Changes in the sound of the voice (dysphonia) - Difficulty passing urine or a feeling that your bladder has not completely emptied (urinary retention) - An abnormal heart trace (QT interval prolongation) potentially leading to an abnormal heart rhythm - Distorted sense of taste (dysgeusia) - Throat irritation - Inflammation of the mouth (stomatitis) - Increased blood pressure - Agitation - Rash - Itching of the skin
Maltese: (żamma tal-awrina) - Traċċar mhux normali tal-qalb (titwil tal-intervall QT) li potenzjalment iwassal għal ritmu mhux normali tal-qalb - Sens mibdul tat-togħma (disgewżja) - Irritazzjoni fil-griżmejn - Infjammazzjoni tal-ħalq (stomatite) - Żieda fil-pressjoni tad-demm - Aġitazzjoni - Raxx - Ħakk fil-ġilda
English: Adverse reactions associated with Duaklir Genuair were similar to those of the individual components.
Maltese: Reazzjonijiet avversi assoċjati ma' Duaklir Genuair kienu simili għal dawk tal-komponenti individwali.
English: Similarly, in pooled clinical studies with Duaklir Genuair/Brimica Genuair and its mono-component, ‘peripheral oedema' was numerically less common on the active treatment than on placebo.
Maltese: B'mod simili, fl-istudji kliniċi miġbura b'Duaklir Genuair/Brimica Genuair u l-monokomponent tiegħu, “edema periferali” kienet numerikament inqas komuni fuq il-kura attiva milli fuq il-plaċebo.
English: The number of steps/day in the Duaklir Genuair treatment group was maintained resulting in a treatment effect compared to placebo of 510 steps/day (p=0.1588) and a reduction versus placebo in the percentage of inactive patients (<6000 steps per day) (41.5% compared to 50.4%; p=0.1134).
Maltese: Innumru ta' passi/jum fil-grupp ta' kura b'Duaklir Genuair inżamm u rriżulta f'effett ta' kura meta mqabbel mal-plaċebo ta' 510 pass/jum (p=0.1588) u tnaqqis kontra l-plaċebo fil-perċentwali ta' pazjenti mhux attivi (<6000 pass kuljum) (41.5% meta mqabbel ma' 50.4%; p=0.1134).
English: Duaklir Genuair demonstrated a rapid onset of action within 5 minutes of the first inhalation relative to placebo (p<0.0001).
Maltese: Duaklir Genuair wera bidu ta' azzjoni rapida fi żmien 5 minuti mill-ewwel teħid tan-nifs relattiv għal plaċebo (p<0.
English: Duaklir Genuair provided a clinically meaningful improvement in disease-specific health status (as assessed by the St. George's Respiratory Questionnaire [SGRQ]) in study AUGMENT, with an improvement in the SGRQ total score compared to placebo of -4.35 units (p<0.0001).
Maltese: George (Respiratory Questionnaire-[SGRQ]) fi studju AUGMENT, b'titjib fil-punteġġ totali tal-SGRQ meta mqabbel ma' plaċebo ta' -4.35 unità (p<0.
English: How to store Duaklir Genuair
Maltese: X'inhu Duaklir Genuair
English: In clinical studies, paradoxical bronchospasm was not observed with Duaklir Genuair at its recommended dose.
Maltese: Fi studji kliniċi ġie osservat bronkospażmu paradossali b'Duaklir Genuair fid-doża rakkomandata tiegħu.
English: Pooled efficacy analysis of the two 6-month Phase III studies demonstrated a statistically significant reduction of 29% in the rate of moderate or severe exacerbations (requiring treatment with antibiotics or corticosteroids or resulting in hospitalisations) with Duaklir Genuair compared to placebo (rates per patient per year: 0.29 vs. 0.42, respectively; p=0.036).
Maltese: III uriet tnaqqis statistikament sinifikanti ta' 29% fir-rata ta' taħrix moderat jew sever tal-marda (li kien jeħtieġ kura b'antibijotiċi jew kortikosterojdi jew li rriżulta f'li l-pazjent kellu jiddaħħal l-isptar) b'Duaklir Genuair meta mqabbel ma' plaċebo (rati għal kull pazjent kull sena: 0.29 vs. 0.42, rispettivament; p=0.036).
English: As Duaklir Genuair contains aclidinium and formoterol, the type and severity of adverse reactions associated with each of the components may be expected with Duaklir Genuair.
Maltese: Peress li Duaklir Genuair fih aclidinium u formoterol, it-tip u s-severità tar-reazzjonijiet avversi assoċjati ma' kull wieħed mill-komponenti jistgħu jkunu mistennija b'Duaklir Genuair.
English: The frequencies assigned to the adverse reactions are based on crude incidence rates observed with Duaklir Genuair 340 micrograms /12 micrograms in the pooled analysis of randomised, placebo-controlled Phase III clinical studies of at least six months duration, or on experience with individual components.
Maltese: Il-frekwenzi assenjati għar-reazzjonijiet avversi huma bbażati fuq rati ta' inċidenza approssimattivi osservati b'Duaklir Genuair 340 mikrogramma /12-il mikrogramma fl-analiżi miġbura ta' studji kliniċi ta' Fażi
English: The pooled analysis of these two studies showed Duaklir Genuair to be associated with statistically significantly greater improvements in TDI focal score compared to aclidinium (0.4 units, p=0.016) or formoterol (0.5 units, p=0.009).
Maltese: L-analiżi miġbura ta' dawn iż-żewġ studji uriet li Duaklir Genuair huwa assoċjat ma' titjib statistikament sinifikanti ferm akbar fil-punteġġ fokali tat-TDI meta' mqabbel ma' aclidinium (0.4 unitajiet, p=0.016) jew formoterol (0.5 unitajiet, p=0.009).
English: Patients with a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, QTc (Bazett's method) above 470 msec, or hospitalisation within the previous 12 months for heart failure functional classes III and IV as per the “New York Heart Association” were excluded from the clinical studies, therefore Duaklir Genuair should be used with caution in these patients groups.
Maltese: Il-pazjenti b'infart mijokardijaku matul is-6 xhur preċedenti, b'anġina instabbli, b'arritmija li tkun għadha kif ġiet iddijanjostikata matul l-aħħar 3 xhur, QTc (metodu ta' Bazett) itwal minn 470 msek, jew li ddaħħlu l-isptar matul l-aħħar 12-il xahar għal insuffiċjenza kardijaka tal-klassijiet funzjonali
English: What Duaklir Genuair contains - The active substances are aclidinium and formoterol fumarate dihydrate.
Maltese: X'fih Duaklir Genuair - Is-sustanzi attivi huma aclidinium u formoterol fumarate dihydrate.
English: Nevertheless, it is considered unlikely that Duaklir Genuair administered at the recommended dose will affect fertility in humans.
Maltese: Madankollu, huwa kkunsidrat improbabbli li Duaklir Genuair mogħti bid-doża rakkomandata jaffettwa l-fertilità fil-bnedmin.
English: High doses of Duaklir Genuair may lead to exaggerated anticholinergic and/or β2-adrenergic signs and symptoms; the most frequent of which include blurred vision, dry mouth, nausea, muscle spasm, tremor, headache, palpitations and hypertension.
Maltese: Dożi għoljin ta' Duaklir Genuair jistgħu jwasslu għal sinjali u sintomi ta' antikolinerġiċi u/jew adrenerġiċi β2 esaġerati; li l-aktar frekwenti minnhom huma vista mċajpra, ħalq xott, dardir, spażmi fil-muskoli, rogħda, uġigħ ta' ras, palpitazzjonijiet u pressjoni għolja.
English: During the reporting period of the PSUR, study D6560C00002 was completed and showed that the proportion of patients with an adverse event of ‘peripheral oedema' was numerically lower in the aclidinium group than in the placebo group.
Maltese: Waqt il-perjodu tar-rappurtar tal-PSUR, intemm l-istudju D6560C00002 u wera li l-proporzjon ta' pazjenti b'avveniment avvers ta' “edema periferali” kien numerikament iktar baxx fil-grupp ta' aclidinium milli fil-grupp tal-plaċebo.
English: The Instructions for Use is divided into the following sections: - Getting started - Step 1: Prepare your dose - Step 2: Inhale your medicine - Additional information
Maltese: - Biex tibda - Pass 1: Ipprepara d-doża tiegħek - Pass 2: Iġbed man-nifs il-mediċina tiegħek - Informazzjoni addizzjonali
English: Do not use Duaklir Genuair: - if you are allergic to aclidinium, formoterol fumarate dihydrate or to the other ingredient of this medicine (listed in section 6).
Maltese: Tużax Duaklir Genuair: - jekk inti allerġiku għal aclidinium, formoterol fumarate dihydrate jew għal xi sustanza oħra ta' din il-mediċina, lactose (imniżżla fis-sezzjoni 6).
English: Before use:
Maltese: Manifattur:
English: If you use more Duaklir Genuair than you should If you think you may have used more Duaklir Genuair than you should, you are more likely to experience some of its side effects, such as blurred vision, dry mouth, feeling sick, shaking/tremor, headache, palpitations or an increase in blood pressure, therefore you must immediately contact your doctor or go to the nearest emergency unit.
Maltese: Jekk taħseb li użajt Duaklir Genuair aktar milli suppost, huwa aktar probabbli li jkollok xi effetti sekondarji tiegħu, bħal vista mċajpra, ħalq xott, dardir, rogħda/tertir, uġigħ ta' ras, palpitazzjonijiet jew żieda fil-pressjoni tad-demm, għaldaqstant għandek tikkuntattja immedjatament lit-tabib tiegħek jew tmur fl-eqreb taqsima ta' emerġenza.
English: Never breathe out into the inhaler (Figure I).
Maltese: Qatt titfa' nnifs 'il barra ġewwa l-inalatur (Figura I).
English: No clinically relevant effects of Duaklir Genuair on ECG parameters (including QT-interval) compared with aclidinium, formoterol and placebo were seen in Phase III studies of 6 to 12 months duration conducted in approximately 4,000 patients with COPD.
Maltese: Ma ntwera ebda effett klinikament rilevanti ta' Dukalir Genuair fuq il-parametri ECG (inkluż intervall tal-QT) meta mqabbel ma' aclidinium, formoterol u plaċebo fl-istudji ta' Fażi
English: Duaklir Genuair 340 micrograms /12 micrograms inhalation powder
Maltese: Duaklir Genuair 340 mikrogramma/12-il mikrogramma trab li jittieħed man-nifs.
English: Dry mouth has been observed with medicines like Duaklir Genuair.
Maltese: Ħalq xott ġie osservat b'mediċini bħal Duaklir Genuair.
English: Date of last renewal: 08/02/2006
Maltese: Data tal-aħħar tiġdid: 08/02/2006
English: Norbrook Laboratories Limited Station Works, Camlough Road, Newry, County Down, BT35 6JP
Maltese: Norbrook Laboratories Limited Station Works, Camlough Road, Newry, County Down,
English: ATC vet code: QJ51FF90
Maltese: QJ51FF90.
English: Anhydrous citric acid
Maltese: Anhydrous citric acid Sodium citrate
English: Pirlimycin has a basic pKa (8.5).
Maltese: Pirlimycin għandu pKa bażiku (8.5).
English: Pirlimycin hydrochloride is a semi-synthetic lincosamide antibiotic.
Maltese: Pirlimycin hydrochloride huwa antibijotiku linkosamid semi-sintetiku.
English: Pirlimycin Bovine 100 µg/kg 100 µg/kg
Maltese: 100 µg/kg 100 µg/kg 1000 µg/kg 400 µg/kg 100 µg/kg
English: Meat and offal: 23 days.
Maltese: Laħam u interjuri: 23 ġurnata.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 50 mg Pirlimycin
Maltese: TAS-SUSTANZA(i) ATTIVA(I) 50 mg pirlimycin.
English: The lincosamides (clindamycin, lincomycin, and pirlimycin) inhibit protein synthesis in Gram-positive and in anaerobic bacteria as well as in Mycoplasma spp.
Maltese: Il-linkosamidi (clindamycin, lincomycin, u pirlimycin) jimblokkaw is-sintesi ta' proteini f'mikrobi Gram-positive u anerobiċi kif ukoll fi speċi ta' Mycoplasma.
English: The active substance in Pirsue 5mg/ml intramammary solution for cattle is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f' PIRSUE 5 mg/ml soluzzjoni intramammarja għal baqar hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010:
English: Resistance against pirlimycin.
Maltese: Reżistenza għall-pirlimycin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/01/2001
Maltese: Data tal-ewwel awtorizazzjoni: 29/01/2001
English: Treatment of infections due to Gram-negative bacteria such as E. coli.
Maltese: Kura għal infezzjonijiet ikkawżati minn mikrobi Gram-negative bħal E. coli.
English: Of the dose infused, 10-13% is excreted in the urine, and 24-30% via the faeces; the remainder is excreted in the milk.
Maltese: Mid-doża mogħtija fl-infużjoni, 10-13% tiġi eliminata fl-urina, u 24-30% fl-ippurgar; il-kumplament joħroġ fil-ħalib.
English: Keep the syringes in the original container.
Maltese: Żomm is-siringi fil-kontenitur oriġinali.
English: Administration: by intramammary infusion only.
Maltese: Amministrazzjoni: permezz ta' infużjoni intramammarja biss.
English: Also packaged as 120 x 10 ml syringes in a plastic bucket.
Maltese: Jiġu ppakkjati wkoll bħala 120 x 10 ml siringa f'barmil tal-plastik.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pirsue 5 mg/ml
Maltese: Pirsue 5 mg/ml
English: 6.5 Nature and composition of immediate packaging Sterile aqueous solution in 10 ml polyethylene intramammary syringes, packaged as 8 x 10 ml, 24 x 10 ml in an outer cardboard box.
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mall-prodott Soluzzjoni sterili akweja f'siringi intramammarji tal-polyethylene ta' 10 ml, ippakkjati f'8 x 10 ml, 24 x 10 ml f'kaxxa tal-kartun.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 8 x 10 ml syringes in an outer carton box 24 x 10 ml syringes in an outer carton box, including 3 package inserts 120 x 10 ml syringes in a plastic bucket, including 15 package inserts
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA 8 siringi x 10 ml f'kaxxa tal-kartun 24 siringi x 10 ml f'kaxxa tal-kartun, bi tlett fuljetti ta' tagħrif 120 siringa x 10 ml f'barmil tal-plastik, bi ħmistax-il fuljett ta' tagħrif
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pirsue 5 mg/ml intramammary solution for cattle
Maltese: VETERINARJU Pirsue 5 mg/ml soluzzjoni intramammarja għal baqar
English: BATCH NUMBER Lot{number}
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID