FrancophonIA/ELRC3.0 huggingface dataset:
English: In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Elebrato Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
Maltese: 001) għal pazjenti kkurati bi Elebrato Ellipta (42%) meta mqabbel ma' FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) u UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
English: In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Elebrato Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
Maltese: 001) għal Elebrato Ellipta meta mqabbel ma' BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
English: In vitro plasma protein binding in human plasma of fluticasone furoate was high, on average >99.6%.
Maltese: It twaħħil ta' fluticasone furoate mal-proteini tal-plażma in vitro fil-plażma tal-bniedem kien għoli, bħalamedja >99.6 %.
English: In FULFIL, the proportion of patients who were CAT responders (defined as 2 units below baseline or lower) at week 24, was significantly higher (p<0.001) for patients treated with Elebrato Ellipta compared with BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75).
Maltese: F'FULFIL, il-proporzjon ta' pazjenti li kienu rispondenti għal CAT (definiti bħal 2 unitajiet taħt il-linja bażi jew aktar baxx) kien f'ġimgħa 24, kien sinifikament ogħla (p<0.001) għal pazjenti kkurati bi Elebrato Ellipta meta mqabbel ma' BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75).
English: In Study 200812, Elebrato Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24.
Maltese: Fi studju 200812, Elebrato Ellipta kien noninferjuri meta mqabbel ma' FF/VI+UMEC, mogħti flimkien f'żewġ inalaturi, fit-titjib mil-linja bażi f'FEV1 minimu f'Ġimgħa 24.
English: Elebrato Ellipta significantly improved (p<0.001) lung function (as defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was maintained in the subset of patients who continued treatment to week 52.
Maltese: 001) il-funzjoni tal-pulmun (kif definite minn bidla medja mil-linja bażi f'FEV1 minimu f'ġimgħa 24) (ara Tabella 1) u t-titjib inżamm f'subsett ta' pazjenti li komplew il-kura sa ġimgħa 52.
English: Co-administration of Elebrato Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Maltese: Antimuskariniċi oħra li jaġixxu fit-tul u agonisti beta2 adrenerġiċi li jaġixxu fit-tul L-għoti flimkien ta' Elebrato Ellipta ma' antimuskariniċi li jaġixxu fit-tul u agonisti beta2 adrenerġiċi li jaġixxu fit-tul ma ġiex studjat u mhuwiex rakkomandat peress li dan jista' jkollu potenzjal għal reazzjonijiet avversi (ara sezzjoni 4.8 u sezzjoni 4.9).
English: The efficacy of Elebrato Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study.
Maltese: L-effikaċja ta' Elebrato Ellipta (92/55/22 mikrogramma) mogħti bħala kura ta' darba kuljum ġiet ivvalutata f'pazjenti b'dijanjożi klinika ta' COPD f'żewġ studji kkontrollati attivi u fi studju wieħed mhux ta' inferjorità.
English: Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Maltese: Elebrato Ellipta 92 mikrogramma/55 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel fluticasone furoate/umeclidinium/vilanterol
English: Elebrato Ellipta contains lactose
Maltese: Elebrato Ellipta fih lactose
English: Also contains lactose and magnesium stearate.
Maltese: Fih ukoll lattożju u magnesium stearate.
English: In FULFIL, Elebrato Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
Maltese: 001) l-użu ta' medikazzjoni ta' salvataġġ bejn ġimgħat 1-24 meta mqabbel ma' BUD/FOR (differenza fil-kura: -0.2 okkażjonijiet għal kull jum; 95% CI: -0.3, -0.1).
English: UK
Maltese: Deutschland
English: Package leaflet: Information for the patient Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Maltese: Informazzjoni għall-pazjent Elebrato Ellipta 92 mikrogramma/55 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel fluticasone furoate/umeclidinium/vilanterol
English: Talk to your doctor before using Elebrato Ellipta - if you have asthma (Don't use Elebrato Ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (TB) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances
Maltese: - jekk għandek l-ażżma (Tużax Elebrato Ellipta biex tikkura l-ażżma) - jekk għandek problemi fil-qalb jew pressjoni tad-demm għolja - jekk għandek problemi fil-fwied - jekk għandek it-tuberkulożi (TB) tal-pulmun, jew kwalunkwe infezzjoni li ilha preżenti jew li ma ġietx ikkurata għal żmien twil - jekk għandek problema fl-għajnejn imsejħa glawkoma tal-angolu dejjaq. - jekk għandek prostata mkabbra, diffikultà biex tgħaddi l-awrina jew imblokk fil-bużżieqa tal awrina tiegħek - jekk tbati minn epilessija - jekk għandek problemi fil-glandola tat-tirojde - jekk għandek livell ta' potassju baxx fid-demm tiegħek - jekk għandek storja ta' dijabete - Jekk tesperjenza vista mċajpra jew disturbi viżivi oħrajn
English: Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation.
Maltese: Wara dożaġġ ripetut ta' fluticasone furoate /vilanterol miġbud bin-nifs, listat fiss inkiseb fi żmien 6 ijiem b'sa akkumulazzjoni ta' 1.6 darba
English: In IMPACT, treatment with Elebrato Ellipta reduced the annual rate of severe exacerbations (i.e., requiring hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064).
Maltese: F'IMPACT, il-kura bi Elebrato Ellipta naqqset ir-rata annwali ta' taħrix sever (jiġifieri, li jeħtieġ dħul flisptar jew li jirriżulta f'mewt) bi 13 % meta mqabbel ma' F/VI (95% CI: -1, 24; p=0.064).
English: Patients with moderate to severe hepatic impairment receiving Elebrato Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Maltese: Pazjenti b'indebboliment tal-fwied moderat sa sever li jkunu qed jirċievu Elebrato Ellipta għandhom jiġu mmonitorjati għal reazzjonijiet avversi relatati mal-kortikosterojdi (ara sezzjoni 5.2).
English: No clinically relevant effects of hypokalaemia were observed in clinical studies with Elebrato Ellipta at the recommended therapeutic dose.
Maltese: Fi studji kliniċi b'Elebrato Ellipta ma ġie osservat l-ebda effett klinikament relevanti ta' ipokalimja bid-doża terapewtika rakkomandata.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Elebrato Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeferiet l-obbligu li jiġu ppreżentati r-riżultati tal-istudji bi Elebrato Ellipta fis-subsettijet kollha tal-popolazzjoni pedjatrika f'COPD (ara sezzjoni 4.2 għal informazzjoni dwar lużu pedjatriku).
English: Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (equivalent to 65 micrograms umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).
Maltese: Kull doża mogħtija fiha 92 mikrogramma ta' fluticasone furoate, 55 mikrogramma ta' umeclidinium (ekwivalenti għal 65 mikrogramma ta' umeclidinium bromide) u 22 mikrogramma ta' vilanterol (bħala trifenatate).
English: Treatment with Elebrato Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Maltese: Il-kura b'Elebrato Ellipta għandha titwaqqaf immedjatament jekk ikun iseħħ bronkospażmu paradossali.
English: Don't use Elebrato Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tużax Elebrato Ellipta: - jekk inti allerġiku għal fluticasone furoate, umeclidinium, vilanterol jew għal xi sustanza oħra ta' din il-mediċina (elenkata fis-sezzjoni 6).
English: Elebrato Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1237/003
Maltese: EU/1/17/1236/001 EU/1/17/1236/002 EU/1/17/1236/003
English: There are no clinical data to support the use of Elebrato Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Maltese: M'hemm l-ebda dejta klinika biex tappoġġja l-użu ta' Elebrato Ellipta għall-kura ta' episodji akuti ta' bronkospażmu, jew biex tikkura taħrix akut ta' COPD (jiġifieri bħala terapija ta' salvataġġ).
English: A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Maltese: Dan il-prodott mediċinali fih il-lattożju.
English: Dose counter
Maltese: Kondizzjonijiet koeżistenti
English: How to store Elebrato Ellipta 6.
Maltese: Kif għandek taħżen Elebrato Ellipta 6.
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore caution should be exercised (see section 4.4).
Maltese: Kura konkomitanti ipokalimika b'derivati ta' methylxanthine, sterojdi, jew dijuretiċi li jħallu il-potassju joħroġ fl-awrina jista' jkollha l-potenzjal għall-effett ipokalimiku possibbli ta' agonisti beta2 adrenerġiċi, għalhekk għandha tiġi eżerċitata l-kawtela (ara sezzjoni 4.4).
English: In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Elebrato Ellipta and budesonide/formoterol arms was equal at 2%.
Maltese: Fis-subsett ta' 430 pazjent kkurati sa 52 ġimgħa, l-inċidenza ta' avvenimenti ta' pulmonite rrappurtati kemm fil-fergħa ta' Elebrato Ellipta kif ukoll ta' budesonide/formoterol kienet daqs 2 %.
English: DE-23812 Wahlstedt GERMANY
Maltese: DE-23812 Wahlstedt
English: ATCvet code: QP53AG30
Maltese: QP53AG30
English: DE-97708 Bad Bocklet-Grossenbrach GERMANY
Maltese: DE-97708 Bad Bocklet-Grossenbrach
English: Labor LS SE & Co. KG Mangelsfeld 4, 5, 6
Maltese: KG Mangelsfeld 4, 5, 6
English: Excipients: Caramel colour (E150d)
Maltese: Kulur il-karamella (E150d)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 colonies treated displaying adverse reaction(s)) - common (more than 1 but less than 10 colonies in 100 colonies treated) - uncommon (more than 1 but less than 10 colonies in 1,000 colonies treated) - rare (more than 1 but less than 10 colonies in 10,000 colonies treated) - very rare (less than 1 colonies in 10,000 colonies treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn waħda minn kull 10 kolonji kkurati juru reazzjoni(jiet) avversa/avversi) - komuni (aktar minn waħda iżda inqas minn 10 kolonji f'100 kolonja kkurata) - mhux komuni (aktar minn waħda iżda inqas minn10 kolonji f'1,000 kolonja kkurata) - rari (aktar minn waħda iżda inqas minn 10 kolonji f'10,000 kolonja kkurata) - rari ħafna (inqas minn kolonja waħda f'10,000 kolonja kkurata, inklużi rapporti iżolati).
English: PACKAGE SIZE 12 x 15 ml
Maltese: DAQS TAL-PAKKETT 12 x 15 ml
English: 19 A - 5164 Seeham AUSTRIA
Maltese: 19 A - 5164 Seeham L-AWSTRIJA
English: 3x up to 5x
Maltese: 3x sa 5x
English: No. of bees VarroMed (ml)
Maltese: VarroMed (ml)
English: Antiinfectious agents
Maltese: Aġenti antiinfettivi
English: BeeVital GmbH Wiesenbergstrasse 19 A-5164 Seeham AUSTRIA
Maltese: BeeVital GmbH Wiesenbergstrasse 19 A - 5164 Seeham L-AWSTRIJA
English: PACKAGE SIZE 555 ml
Maltese: DAQS TAL-PAKKETT 555 ml
English: 4.6 Adverse reactions (frequency and seriousness)
Maltese: Effetti mhux mixtieqa (frekwenza u gravità)
English: Box containing 1 bottle of 555 ml dispersion.
Maltese: Kaxxa li fiha flixkun 1 ta' 555 ml dispersjoni.
English: Pharmacotherapeutic group: Ectoparasiticides for topical use, including insecticides, organic acids, combinations
Maltese: Ektoparassitiċidi għal tużu topiku, inklużi insettiċidi, aċidi organiċi,
English: 15 to 30 ml
Maltese: 15 sa 30 ml
English: VarroMed is available in two pack sizes, multi-dose bottles (1 x 555 ml) and single-dose sachets (12 x 15 ml).
Maltese: VarroMed huwa disponibbli f'żewġ daqsijiet tal-pakketti, fliexken ta' ħafna dożi (1 x 555 ml) u qratas ta' doża waħda (12 x 15 ml).
English: 5 mg/ml Oxalic acid dihydrate 44 mg/ml
Maltese: 5 mg/ml Diitrat tal-aċidu ossaliku 44 mg/ml
English: EXPIRY DATE EXP {month/year}
Maltese: DATA TA' SKADENZA EXP{xahar/sena}
English: The pharmacokinetics of VarroMed have not been studied.
Maltese: Il-farmakokinetika ta' VarroMed ma ġietx studjata.
English: 75 mg Oxalic acid dihydrate 660 mg
Maltese: 75 mg Diitrat tal-aċidu ossaliku 660 mg
English: 30 to 45 ml
Maltese: 30 sa 45 ml
English: 1x or 3x
Maltese: 1x jew 3x
English: Repeated Treatment:
Maltese: Kura ripetuta:
English: N/A Bees
Maltese: M/A L-EBDA
English: N/A NO ENTRY
Maltese: IL-PROVVISTA U L
English: METHOD AND ROUTE(S) OF ADMINISTRATION In-hive use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu fid-doqqajs.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/203/002
Maltese: FIS-SUQ EU/2/16/203/002
English: Following the administration of a 10% solution of oxalic acid dihydrate in 50% sugar solution, permanent lesions in digestive and excretory organs were noted after 72 hours (h).
Maltese: Wara l-għotja ta' soluzzjoni ta' 10 % ta' diitrat ta' aċidu ossaliku f'50 % ta' soluzzjoni taz-zokkor, ġew innotati leżjonijiet permanenti f'organi diġestivi u eskritorajli wara 72 siegħa (h).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/203/001
Maltese: FIS-SUQ EU/2/16/203/001
English: 44 mg (equivalent to 31.42 mg oxalic acid anhydrous)
Maltese: 44 mg (ekwivalenti għal 31.42 mg ta' anidru tal-aċidu ossaliku)
English: Formic acid
Maltese: Aċidu formiku
English: CONTRAINDICATIONS Do not use during nectar flow.
Maltese: KONTRAINDIKAZZJONIJIET Tużax waqt il-fluss tan-nektar.
English: The dose should carefully be adjusted to the colony size (see dosing table).
Maltese: Id-doża għandha tiġi aġġustata b'attenzjoni għad-daqs tal-kolonja (ara t-tabella tad-dożaġġ).
English: administrations).
Maltese: TAMMINISTRA
English: ROUTE(S) OF ADMINISTRATION In-hive use.
Maltese: MOD(I) TA' AMMINISTRAZZJONI Użu fid-doqqajs.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Formic acid
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Sustanzi attivi:
English: Formic acid probably kills Varroa mites by inhibiting electron transport in their mitochondria through the binding of cytochrome c oxidase, thereby inhibiting energy metabolism and may produce a neuroexcitatory effect on arthropod neurons after evaporation in the hive air (at least 500 ppm).
Maltese: L-aċidu formiku probabbilment joqtol id-dud tal-Varroa billi jinibixxi t-trasport tal-elettroni fil mitokondrija tagħhom permezz tal-irbit tal-ossidażi taċ-ċitokromju ċ, b'hekk jinibixxi l-metaboliżmu tal-enerġija u jista' jipproduċi effett newro stimulanti fuq in-newroni antropodi wara l-evaporazzjoni fl-arja tad-doqqajs (mill-inqas 500 ppm).
English: Season
Maltese: Staġun
English: VarroMed should only be used as part of an integrated Varroa control programme.
Maltese: VarroMed għandu jintuża biss bħala parti minn programm integrat ta' kontroll ta' Varroa.
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott {numru}
English: Oxalic acid concentrations of 20% in a 50% sugar solution led to acute bee mortalities of more than
Maltese: Konċentrazzjonijiet ta' aċidu ossaliku ta' 20 % f'soluzzjoni ta' 50 % ta' zokkor wasslu għal mortalità tan-naħal akuti ta' aktar minn 60 %.
English: Caramel colour (E150d) Sucrose syrup Propolis tincture 20% Star anise oil Lemon oil
Maltese: Lista ta' ingredjenti Kulur il-karamella (E150d) Ġulepp taz-zokkor
English: 6.2 Major incompatibilities
Maltese: Inkompatibilitajiet maġġuri
English: 660 mg (equivalent to 471.31 mg oxalic acid)
Maltese: Diitrat tal-aċidu ossaliku 660 mg (ekwivalenti għal 471.31 mg aċidu ossaliku)
English: Keep the sachets in the outer carton in order to protect from light.
Maltese: Inġestjoni aċċidentali tista' tikkawża reazzjonijiet avversi.
English: Formic acid /oxalic acid dihydrate
Maltese: Aċidu formiku/diitrat tal-aċidu ossaliku
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/203/002 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02/02/2017
Maltese: Data tal-ewwel awtorizzazzjoni: 02/02/2017
English: Cardboard box containing 12 single-dose sachets (foil PETP/ Al /LDPE), each containing 15 ml dispersion.
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mal-prodott Kaxxa tal-kartun li fiha 12 il-qartas ta' doża waħda (fojl PETP/ Al /LDPE), li kull wieħed fih 15 ml dispersjoni.
English: 5.2 Pharmacokinetic particulars
Maltese: Tagħrif farmakokinetiku
English: INDICATION(S) Treatment of varroosis (Varroa destructor) in honey bee colonies with and without brood.
Maltese: INDIKAZZJONI (JIET) Kura tal-varroażi (Varroa destructor) f'kolonji tan-naħal bl-għasel bi jew mingħajr duqqajs.
English: In order to establish the Varroa infestation level in a hive, the mite mortality must be monitored: mite fall should be recorded on the hive floorboard before the first treatment, and up to 6 days after each treatment.
Maltese: Sabiex jiġi stabbilit il-livell tal-infestazzjoni ta' Varroa f'doqqajs, għandha tiġi mmonitorjata l mortalità tad-dud: it-twaqqigħ tad-dud għandu jiġi rreġistrat fuq il-floorboard tad-doqqajs qabel lewwel kura, u sa 6 ijiem wara kull kura.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion for honey bees
Maltese: VarroMed 5 mg/ml + 44 mg/ml tixrid tad-doqqajs
English: PHARMACOLOGICAL PROPERTIES
Maltese: KWANTITAJIET FARMAKOLOĠIĊI
English: Citric acid monohydrate Purified water
Maltese: Żejt tal-lumi Aċidu ċitriku monoidrat
English: Each single dose sachet contains:
Maltese: La darba jkun miftuħ, uża sa:
English: 44 mg (equivalent to 31.42 mg oxalic acid)
Maltese: Diitrat tal-aċidu ossaliku 44 mg (ekwivalenti għal 31.42 mg aċidu ossaliku)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 75 mg + 660 mg bee-hive dispersion Formic acid/oxalic acid dihydrate
Maltese: VarroMed 75 mg + 660 mg tixrid tad-doqqajs għan-naħal tal-għasel
English: Each ml contains:
Maltese: GĦAL:
English: Multi-dose container (bottle)
Maltese: Kontenitur ta' ħafna dożi (flixkun)
English: The acaricidal effect may be due mainly to the low pH of the formulation.
Maltese: L-effett akariċidali jista' jkun l-aktar minħabba l pH baxx tal-formulazzjoni.
English: Treatment of varroosis (Varroa destructor) in honey bee colonies with and without brood.
Maltese: Kura tal-varroażi (Varroa destructor) f'kolonji tan-naħal bl-għasel bi jew mingħajr duqqajs.
English: For the full list of excipients, see section 6.1.
Maltese: Ilma ppurifikat 6.2.
English: Increased mortality in worker bees was very commonly observed in the clinical and preclinical trials following treatment with Varromed.
Maltese: Ġiet osservata b'mod komuni ħafna żieda fil-mortalità tan-naħal ħaddiem fi provi kliniċi u prekliniċi wara l-użu b'Varromed.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion Formic acid/oxalic acid dihydrate
Maltese: VarroMed 5 mg/ml + 44 mg/ml tixrid tad-doqqajs għan-naħal tal-għasel
English: 660 mg (equivalent to 471.31 mg oxalic acid anhydrous)
Maltese: Diidrat tal-aċidu ossaliku 660 mg (ekwivalenti għal 471.31 mg ta' anidru tal-aċidu ossaliku) Ingredjenti mhux attivi:
English: The excipients, listed in section 6.1 of the SPC areeither allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Maltese: Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: No data are available which confirm this activity after trickling of 0.5% formic acid; however, formic acid in the fixed combination of VarroMed is considered to extend the duration of the effect of oxalic acid, and to improve the tolerance of the product.
Maltese: M'hemm l-ebda data disponibbli li tikkonferma din l-attività wara t-taqtir ta' 0.5 % ta' aċidu formiku; madankollu, l-aċidu formiku fil-kombinazzjoni fissa ta'
English: Efficacy was only investigated in hives with low to moderate mite infestation rates.
Maltese: L-effikaċja ġiet investigata biss f'doqqajs b'rati baxxi għal moderati ta' infestazzjoni tad-dudu.
English: None known.
Maltese: Żero jiem.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Maltese: Staqsi lillkirurgu veterinarju jew lill-ispiżjar tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: The following dosing scheme applies:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: Disposal: read the package leaflet.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu jitqiegħdu fis-suq.
English: No MRL required
Maltese: L-ebda MRL
English: Winter (broodless)
Maltese: INDIKAZZJONI (JIET)
English: No. of applications
Maltese: Mhux applikabbli
English: 6.5 Nature and composition of immediate packaging Cardboard box containing an HDPE bottle with dropper nozzle (LDPE) and screw cap (with tamper evident seal).
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mal-prodott Kaxxa tal-kartun li fiha flixkun HDPE b'żennuna qattara (LDPE) u b'għatu bil-kamini (b'siġill li jurik jekk jiġi mbagħbas).
English: The multi-dose container has a graduated dosing scale for accurate dosing.
Maltese: Id-dlam jiffaċilita d-distribuzzjoni tal-prodott bejn in-naħal.
English: PHARMACEUTICAL FORM Bee-hive dispersion.
Maltese: Għall-kura tal-annimali biss.
English: The treatment should be repeated twice more (that is to a maximum of 5 treatments), if more than 150 mites (colonies from the second year) or more than 90 mites (nucleus colonies in the first year) are detected on the floorboard within 6 days after the third administration.
Maltese: Il-kura għandha tiġi rrepetuta darbtejn aktar (jiġifieri għal massimu ta' 5 kuri), jekk jiġu skoperti aktar minn 150 dudu (koloniji mit-tieni sena) jew aktar minn 90 dudu (kolonji ċentrali fl-ewwel sena) fuq il floorboard fi żmien 6 ijiem wara t-tielet għotja.
English: Manufacturer responsible for batch release:
Maltese: Ingredjenti mhux attivi:
English: It is advised to check regularly that the queen is present, but avoid disturbing the hives in the days following treatment.
Maltese: Huwa rrakkomandat li tiċċekkja b'mod regolari li r-reġina hija preżenti, iżda evita li tfixkel id-doqqajs fil jiem ta' wara l-kura.
English: Do not use this veterinary medicinal product after the expiry date, which is stated on the carton after “EXP”.
Maltese: Tużax dan il-prodott mediċinali veterinarju wara d-data ta' skadenza, li tidher fuq il-flixkun wara “EXP”.
English: Honey: Zero days.
Maltese: Għasel: Żero jiem.
English: No of applications
Maltese: Nru. ta' applikazzjonijiet