FrancophonIA/ELRC3.0 huggingface dataset:
English: Flupirtine-containing medicines have been authorised since the 1980s and are currently available in the following EU Member States: Estonia, Germany, Latvia, Lithuania, Luxembourg, Poland, Portugal, and Slovakia.
Maltese: Il-mediċini li fihom flupirtine ilhom awtorizzati sa mis-snin tmenin u fil-preżent huma disponibbli flIstati Membri li ġejjin: l-Estonja, il-Ġermanja, il-Latvja, il-Litwanja, il-Lussemburgu, il-Polonja, ilPortugall u s-Slovakkja.
English: 2 These cases have been reported in the European database of suspected adverse drug reaction reports (Eudravigilance) between April 2013 and December 2017
Maltese: 2 Dawn il-każijiet ġew irrappurtati fid-dejtabejż Ewropea ta' rapporti ta' reazzjonijiet avversi għal mediċina ssuspettati (Eudravigilance) bejn April 2013 u Diċembru 2017.
English: Flupirtine works as a ‘selective neuronal potassium channel opener'.
Maltese: Flupirtine jaħdem bħala “aġent li jiftaħ il-kanal tal-potassju newronali selettiv”.
English: The review of flupirtine was initiated on 26 October 2017 at the request of Germany, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' flupirtine nbdiet fis-26 ta' Ottubru 2017 fuq talba mill-Ġermanja, skont L-Artikolu 31 tad-Direttiva 2001/83/KE.
English: In order to protect public health, the CMDh endorsed the PRAC recommendation to withdraw the marketing authorisations of flupirtinecontaining medicines.
Maltese: Sabiex jipproteġi s-saħħa pubblika, isCMDh approva r-rakkomandazzjoni tal-PRAC sabiex jirtira l-awtorizzazzjonijiet għat-tqegħid fis-suq talmediċini li fihom flupirtine.
English: • Restrictions introduced in 2013, which included limiting flupirtine use to two weeks and regular monitoring of liver function tests, have not been sufficiently followed in clinical practice.
Maltese: • Ir-restrizzjonijiet introdotti fl-2013, li kienu jinkludu l-limitazzjoni tal-użu ta' flupirtine għal ġimagħtejn u monitoraġġ regolari tat-testijiet tal-funzjoni tal-fwied, ma ġewx segwiti biżżejjed filprassi klinika.
English: The PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position on 21 March 2018.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lillGrupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura DeċentralizzataBniedem (CMDh), li adotta pożizzjoni fil-21 ta' Marzu 2018.
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: Huwa responsabbli biex jiżgura standards armonizzati dwar is-sigurtà għall-mediċini awtorizzati permezz tal-proċeduri nazzjonali madwar l-UE kollha.
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Maltese: Is-CMDh huwa korp li jirrappreżenta lIstati Membri tal-UE kif ukoll l-Iżlanda, il-Liechtenstein u n-Norveġja.
English: Withdrawal of pain medicine flupirtine endorsed
Maltese: Aktar dwar il-mediċina
English: The opening of these channels reduces the excessive electrical activity that leads to many pain states.
Maltese: Il-ftuħ ta' dawn il-kanali jnaqqas l-attività elettrika eċċessiva li twassal għal ħafna stati ta' uġigħ.
English: • Flupirtine-containing medicines are being taken off the market in the EU because of the risk of serious liver injury.
Maltese: • Il-mediċini li fihom flupirtine qegħdin jitneħħew mis-suq tal-UE minħabba r-riskju ta' ħsara serja filfwied.
English: The CMDh1 has endorsed EMA's recommendation to withdraw the marketing authorisation for the pain medicine flupirtine, because of the risk of serious liver injury.
Maltese: Is-CMDh1 approva r-rakkomandazzjoni tal-EMA sabiex tiġi rtirata l-awtorizzazzjoni għat-tqegħid fis-suq għall-mediċina għall-uġigħ flupirtine, minħabba r-riskju ta' ħsara serja fil-fwied.
English: • Flupirtine-containing medicines have been used to treat acute (short-term) pain for up to two weeks in adults who cannot use other painkillers (such as non-steroidal anti-inflammatory drugs (NSAIDs) and weak opioids).
Maltese: • Il-mediċini li fihom flupirtine ntużaw biex jikkuraw uġigħ (għal perjodu qasir) akut sa ġimagħtejn f'adulti li ma jistgħux jużaw mediċini oħra li jtaffu l-uġigħ (bħal antinfjammatorji nonsterojdali (NSAIDs) u opjojdi mhux qawwija).
English: • Six observational studies showed a lack of compliance with the measures that were introduced to minimise the risk of hepatotoxicity.
Maltese: • Sitt studji ta' osservazzjoni wrew nuqqas ta' konformità mal-miżuri li ġew introdotti sabiex jiġi mminimizzat ir-riskju ta' epatotossiċità.
English: It also assessed cases of serious liver damage reported since the 2013 review.
Maltese: Din ivvalutat ukoll każijiet ta' ħsara serja fil-fwied li ġew irrappurtati sa mir-reviżjoni tal-2013.
English: • Since 2013, cases of serious liver injury, including 23 cases of acute liver failure, some of which were fatal or led to transplantation have been reported following flupirtine use.2 The reactions are unpredictable and the exact mechanism by which flupirtine causes liver injury is not known.
Maltese: • Sa mill-2013, ġew irrappurtati każijiet ta' ħsara serja fil-fwied, inkluż 23 każ ta' insuffiċjenza akuta tal-fwied, li xi wħud minnhom kienu fatali jew wasslu għal trapjant wara l-użu ta' flupirtine.2 Irreazzjonijiet huma imprevedibbli u l-mekkaniżmu eżatt li bih flupirtine jikkawża ħsara fil-fwied mhuwiex magħruf.
English: The review, carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), looked at the available data including studies evaluating whether the 2013 restrictions were followed in clinical practice.
Maltese: Ir-reviżjoni, li saret mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) tal-EMA, eżaminat id-dejta disponibbli inklużi l-istudji li jevalwaw jekk ir-restrizzjonijiet tal-2013 ġewx segwiti fil-prassi klinika.
English: The CMDh agreed with the PRAC conclusion that the restrictions introduced in 2013 have not been sufficiently followed, and cases of serious liver injury, including liver failure, still occurred.
Maltese: Is-CMDh qabel mal-konklużjoni tal-PRAC li r-restrizzjonijiet introdotti fl-2013 ma ġewx segwiti biżżejjed, u xorta seħħew każijiet ta' ħsara serja fil-fwied, inkluża insuffiċjenza tal-fwied.
English: This means that it opens specific pores on nerve cells called potassium channels.
Maltese: Dan ifisser li jiftaħ pori speċifiċi fiċ-ċelloli tan-nervituri msejħa kanali tal-potassju.
English: • Since 2013, cases of serious liver injury, including 23 cases of acute liver failure (sudden loss of liver function), some of which were fatal or led to transplantation have been reported following flupirtine use.
Maltese: • Sa mill-2013, ġew irrappurtati każijiet ta' ħsara serja fil-fwied, inkluż 23 każ ta' insuffiċjenza akuta tal-fwied (telf f'daqqa tal-funzjoni tal-fwied), li xi wħud minnhom kienu fatali jew wasslu għal trapjant wara l-użu ta' flupirtine.
English: Flupirtine is a medicine used to treat acute (short-lived) pain for up to 2 weeks, in patients who cannot use other painkillers such as opioids or nonsteroidal anti-inflammatory medicines (NSAIDs).
Maltese: Flupirtine hija mediċina li tintuża biex tikkura uġigħ (li ma jdumx) akut sa ġimagħtejn, f'pazjenti li ma jistgħux jużaw mediċini oħra li jtaffu l-uġigħ bħal opjojdi jew mediċini antinfjammatorji nonsterojdali (NSAIDs).
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Maltese: Ir-reviżjoni saret l-ewwel mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC), ilKumitat responsabbli għall-evalwazzjoni ta' kwistjonijiet tas-sigurtà għall-mediċini li jintużaw millbniedem, li għamel sett ta' rakkomandazzjonijiet.
English: • Healthcare professionals in the EU countries where flupirtine is marketed will receive a letter with detailed information on the appropriate actions to be taken, including when the medicine will become unavailable.
Maltese: • Il-professjonisti tal-kura tas-saħħa fil-pajjiżi tal-UE fejn jitqiegħed fis-suq flupirtine ser jirċievu ittra b'informazzjoni ddettaljata dwar l-azzjonijiet xierqa li għandhom jieħdu, inkluż meta l-mediċina ma tibqax disponibbli.
English: The CMDh therefore agreed that patients taking flupirtine-containing medicines continue to be exposed to serious risks which outweigh the benefits of these medicines.
Maltese: Barra minn hekk, ma setgħet tiġi identifikata l-ebda miżura ulterjuri sabiex jitnaqqas ir-riskju ta' problemi fil-fwied.
English: GlaxoSmithKline Pharmaceuticals SA 2-4-6, Avenue Pascal B-1330 Wavre
Maltese: SA 2-4-6, Avenue Pascal B-1330 Wavre
English: - C/ Severo Ochoa, 2 28760 - Tres Cantos Madrid
Maltese: GlaxoSmithKline, S.A. P.T.M. - C/ Severo Ochoa, 2 28760 - Tres Cantos Madrid
English: Eepoprostenol 1.5 mg
Maltese: Epoprostenol 1.5 mg
English: The Wellcome Foundation Ltd. Glaxo Wellcome house Berkeley Avenue Greenford
Maltese: Glaxo Wellcome house Berkeley Avenue Greenford
English: Freeze-Dried Powder
Maltese: Ir-Repubblika Ċeka
English: GlaxoSmithKline, S.A. P.T.M.
Maltese: GlaxoSmithKline Pharmaceuticals
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: 1 vial
Maltese: Kontenut Daqs talpakkett kunjett 1
English: EU Number
Maltese: Numru ta' l-EU Isem Qawwa
English: Method of administration:
Maltese: Metodu ta' amministrazzjoni:
English: Wyeth Lederle Italia S.p.A. 18, Via Franco Gorgone 95121 Catania Italy
Maltese: Wyeth Lederle Italia S.p.A. 18, Via Franco Gorgone 95121 Catania L-Italja
English: 4.6 Adverse reactions (frequency* and seriousness)
Maltese: 4.6 Effetti mhux mixtieqa (frekwenza* u gravità)
English: Pharmacotherapeutic group: ATC Vet Code QP 53AX25
Maltese: .1 Kwalitajiet Farmakodinamiċi Kodici ATĊ veterinarja QP 53AX25
English: Active substance: 160 mg metaflumizone
Maltese: Sustanza attiva: 160 mg metaflumizone
English: BATCH NUMBER LOT {number}
Maltese: NUMRU TAL-LOTT Lot {numru}
English: The recommended minimum dose is 40 mg metaflumizone/kg bodyweight, equivalent to 0.20ml/kg bodyweight.
Maltese: Id-doża minima rakkomandata hija ta' 40 mg metaflumizone/kg piż tal-ġisem, ekwivalent għal 0.20 ml/kg piż tal-ġisem.
English: The solvent in ProMeris may stain certain materials including leather, fabrics, plastics and finished surfaces.
Maltese: Is-solvent li hemm f'Promeris jista' jtebba' xi materjali bħalma hi l-ġilda, tessuti, plastiks u uċuħ iffinixxjati.
English: For use only under the supervision of a veterinary surgeon.
Maltese: Għall-użu taħt is-superviżjoni ta' kirurgu veterinarju biss.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/001-004
Maltese: EU/2/06/064/004
English: Spot-on use.
Maltese: Mhux Applikabbli.
English: Luxembourg Pfizer Animal Health s.a.,
Maltese: Sverige Pfizer Oy Animal Health
English: Metaflumizone is an ectoparasiticide belonging to the semicarbazone group of compounds.
Maltese: Metaflumizone huwa ektoparassiċida li jagħmel parti mill-grupp ta' sustanzi semicarbazone.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For cutaneous use only.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: For optimal control of flea infestation, the veterinary medicinal product can be administered at 4 to 6 week intervals throughout the flea season or the treatment schedule can be based on the local epidemiological situation.
Maltese: Għall-kontroll ottimali ta' infestazzjoni tal-briegħed, il-prodott mediċinali veterinarju jista' jingħata f'intervalli ta' 4 - 6 ġimgħat tul l-istaġun tal-briegħed jew il-programm ta' kura jista' jiġi bbażat fuq is-sitwazzjoni epidemjoloġika lokali.
English: Each ml contains 200 mg metaflumizone.
Maltese: Kull ml fih 200 mg metaflumizone.
English: Excipients For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: PHARMACEUTICAL FORM Spot-on solution A clear, yellow to amber solution
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-Użu Lokalizzat Soluzzjoni ċara, safra sa amber
English: Active substance: 320 mg metaflumizone
Maltese: 320 mg metaflumizone
English: Correct application will minimise licking of the application site.
Maltese: Applikazzjoni korretta tnaqqas li l-annimal jilgħaq il-post ta' applikazzjoni.
English: No adverse effects were observed in cats aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
Maltese: L-ebda effetti avversi ma kienu osservati fi qtates b'età ta' 8 ġimgħat jew aktar ikkurati 7 darbiet f'intervalli ta' ġimagħtejn b'3-5 darbiet id-doża rakkomandata.
English: *- Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - Common (more than 1 but less than 10 animals in 100 animals) - Uncommon (more than 1 but less than 10 animals in 1,000 animals ) - Rare (more than 1 but less than 10 animals in 10,000 animals) - Very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: * - Komuni ħafna (aktar minn 1 f'10 mill-annimali juru effett(i) mhux mixtieq(a) waqt kors wieħed ta'trattament).
English: ProMeris for Small Cats (≤ 4 kg)
Maltese: ProMeris għall-Qtates Żgħar (≤ 4 kg)
English: In sick or debilitated animals, use only according to the benefit/risk assessment by the responsible veterinarian.
Maltese: F'annimali morda jew dgħajjfa, uża biss skond l-analiżi tal-veterinarju responsabbli tal benefiċċji/riskji.
English: Box of 1 blister card of 3 x 0.80 ml pipettes Box of 2 blister cards of 3 x 0.80 ml pipettes
Maltese: Kaxxa b'pakkett f'folja ta' 3 x pipetti ta' 0.80 ml Kaxxa b'2 pakketti f'folja ta' 3 x pipetti ta' 0.80 ml
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/001 - 1 blister card of 3 pipettes of 0.80 ml EU/2/06/064/002 - 2 blister cards of 3 pipettes of 0.80 ml
Maltese: EU/2/06/064/002 - Żewġ pakketti f'folja ta' 3 pipetti ta' 0.80 ml
English: This is not a sign of intoxication and disappears within minutes without treatment.
Maltese: Dan mhux sinjal ta' intossikazzjoni u jgħaddi wara ftit minuti mingħajr kura.
English: ProMeris for Small Cats (≤ 4 kg)*
Maltese: ProMeris għall-Qtates Kbar (> 4 kg)*
English: ProMeris for Large Cats (> 4 kg)
Maltese: ProMeris għall-Qtates Kbar (> 4 kg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 320 mg Spot-on for large cats {> 4 kg}
Maltese: ProMeris 320 mg Spot-on għall-qtates kbar {> 4 kg}
English: These results are consistent with laboratory efficacy studies showing activity for up to 56 days post-treatment.
Maltese: Dawn ir-riżultati huma konsistenti ma' studji ta' l-effikaċja fil-laboratorju li wrew attività sa 56 ġurnata wara l-kura.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Maltese: Il-prodott mediċinali veterinarju jista' jintuża bħala parti minn strateġija ta' kura għal dermatite allerġika tal-bergħud (FAD).
English: Box of 1 blister card of 3 x 1.60 ml pipettes Box of 2 blister cards of 3 x 1.60 ml pipettes
Maltese: Kaxxa b'pakkett f'folja ta' 3 x pipetti ta' 1.60 ml Kaxxa b'2 pakketti f'folja ta' 3 x pipetti ta' 1.60 ml
English: Gamma-hexalactone
Maltese: Synperonic NCA 830 Dimethyl sulfoxide Gamma-hexalactone
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active Substance
Maltese: Sustanza attiva:
English: Dimethyl sulfoxide
Maltese: TWISSIJIET SPEĊJALI
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 1.60 ml pipette delivers:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull pipetta ta' 1.60 ml tagħti:
English: Box of 1 or 2 blister card of 3 x 0.80 ml pipettes Box of 1 or 2 blister card of 3 x 1.60 ml pipettes
Maltese: Kaxxa ta' 1 jew 2 pakketti f'folja ta' 3 x pipetti ta' 0.80 ml Kaxxa ta' 1 jew 2 pakketti f'folja ta' 3 x pipetti ta' 1.60 ml
English: The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the fur at the application site.
Maltese: L-applikazzjoni tal-prodott mediċinali veterinarju tista' tipproduċi dehra temporanjament żejtnija u tagħqid jew ippuntar tal-pil fil-post ta' applikazzjoni.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/003 - 1 blister card of 3 pipettes of 1.60 ml EU/2/06/064/004 - 2 blister cards of 3 pipettes of 1.60 ml
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/06/064/003 - Pakkett f'folja ta' 3 pipetti ta' 01.60 ml
English: Weight Of Cat (kg)
Maltese: Piż tal-Qattus (kg)
English: The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes overpacked in an aluminium foil package.
Maltese: Il-prodott mediċinali veterinarju huwa ppakkjat f'dożi individwali f'pipetti tal-plastik trasparenti li huma ippakkjati mill-ġdid f'pakkett tal-fojl ta' l-aluminju.
English: Marketing authorisation holder Pfizer Limited
Maltese: Sid l-Awtorizzazzjoni tal-Kummerċ : Pfizer Limited
English: ADVERSE REACTIONS*
Maltese: kg)*
English: It is supplied in units of 3 pipettes per cardboard card and one or two cards per cardboard box.
Maltese: Huwa pprovdut f'unitajiet ta' 3 pipetti kull pakkett tal-kartun u kull kaxxa tal-kartun fiha pakkett tal-kartun wieħed jew tnejn.
English: Metaflumizone is active against fleas due to non-systemic exposure of the parasites on the skin and hair.
Maltese: Metaflumizone jaħdem kontra l-briegħed minħabba espożizzjoni mhux sistemika tal-parassiti fuq il-ġilda u l-pil.
English: 4.9 Amounts to be administered and administration route Dosage:
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni
English: In rare cases, transient irritation may occur at the site of the product application.
Maltese: F'każijiet rari, jista' jkun hemm irritazzjoni temporanja fil-post ta' l-applikazzjoni tal-prodott.
English: Carton box for 2 blister cards
Maltese: Kaxxa tal-kartun b'2 pakketti f'folja
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 160 mg Spot-on solution for small cats ProMeris 320 mg Spot-on solution for large cats
Maltese: VETERINARJU ProMeris 160 mg soluzzjoni għall-Użu Lokalizzat għall-qtates żgħar
English: CONTRAINDICATIONS
Maltese: PAKKETT
English: After topical administration at a single site on the cat's neck at the base of the skull, metaflumizone levels in plasma were too low to allow the calculation of standard pharmacokinetic parameters.
Maltese: Wara għotja topika f'post wieħed fuq l-għonq tal-qattus fil-bażi tar-ras, livelli fil-plażma ta' metaflumizone kienu baxxi wisq biex jitħallew li ssir kalkolazzjoni ta' parametri farmakokinetiċi stàndard.
English: Pipette size to be used
Maltese: PERJODU TA' TIŻMIM
English: Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats.
Maltese: Għall-kura u prevenzjoni ta' infestazzjonijiet minn briegħed (Ctenocephalides canis u C. felis) filqtates.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 0.80 ml pipette delivers:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull pipetta ta' 0.80 ml tagħti:
English: For animal treatment only - to be supplied only on veterinary prescription.
Maltese: Biss - għandu jingħata biss bi preskrizzjoni medika.
English: SPECIAL WARNING(S)
Maltese: ProMeris S
English: Cats over 8 weeks of age.
Maltese: Tagħtix lill-frieħ ta' qtates taħt l-età ta' 8 ġimgħat.
English: 4.11 Withdrawal period(s)
Maltese: 3 DIKJARAZZJONI TAS-SUSTANZA(I)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris L
Maltese: Prekawzjonijiet speċjali li għandhom jittieħdu mill-persuna li tamministra l-prodott mediċinali veterinarju lill-annimali
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for 1 blister card -Carton box for 2 blister cards
Maltese: Kaxxa tal-kartun b'pakket f'folja - Kaxxa tal-kartun b'2 pakketti f'folja
English: Τηλ.
Maltese: Biss.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 160 mg Spot-on for small cats {< 4 kg}
Maltese: VETERINARJU ProMeris 160 mg għall-Użu Lokalizzat għall-qtates żgħar
English: Metaflumizone is a sodium channel antagonist and disrupts nerve function resulting in paralysis and death of insects.
Maltese: Metaflumizone huwa antagonist tal-kanal tas-sodju u jtellef il-funzjoni tan-nerv u b'hekk iwassal għall-paraliżi u l-mewt ta' l-insetti.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: 4.2 Indications for use, specifying the target species Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats.
Maltese: INDIKAZZJONI (JIET) Għall-kura u prevenzjoni ta' infestazzjonijiet mill-briegħed (Ctenocephalides canis u C. felis) fil qtates.
English: Maximum concentrations in the hair were generally reached between 1 to 2 days post-treatment and gradually declined through 56 days posttreatment.
Maltese: Konċentrazzjonijiet massimi fil-pil intlaħqu ġeneralment f'madwar ġurnata sa tnejn wara l-kura u naqsu b'mod gradwali tul 56 ġurnata wara l-kura.
English: This is normal and will generally resolve within 1 - 4 days after administration.
Maltese: Dan huwa normali u ġeneralment jgħaddi f'1 - 4 ġranet wara l-applikazzjoni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances
Maltese: KOMPOŻIZZJONI KWALITATTIVA
English: For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide.
Maltese: Dan il-prodott mediċinali veterinarju huwa għall-użu lokalizzat biss.
English: Each unit dose (pipette) of ProMeris delivers:
Maltese: U INGREDJENT(I) OĦRA Sustanzi Attivi :
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTURA RESPONSABBLI GĦALL -HRUĠ TAL-LOTT
English: ProMeris for Large Cats (> 4 kg)* *Due to limited space on the packaging, the abbreviations "S" and "L", which represent "small" and "large", respectively, are used on the blister foil and applicator pipettes.
Maltese: *Minħabba nuqqas ta' spazju, l-abbrevjazzjonijiet “S” u “L”, li jirrappreżentaw “żgħir” u
English: PACKAGE LEAFLET ProMeris Spot-on for cats
Maltese: FIL-PAKKETT ProMeris għall-Użu Lokalizzat għall-qtates
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years 6.4.
Maltese: Żmien li l-prodott mediċinali veterinarju jista' jinżamm fuq l-ixkaffa ippakkjat għall-bejgħ: 3 snin.
English: Conclusions
Maltese: Konklużjonijiet
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP concludes that:
Maltese: Għalhekk, skont l-Artikoli 31 u 32 tad-Direttiva 2001/83/KE, is-CHMP ikkonkluda li:
English: Whereas
Maltese: a.
English: Alternative data were submitted to demonstrate the bioequivalence of Cefuroxime Alkem, Cefuroxime Krka and Cefuroxime Ingen Pharma to an EU reference medicinal product.
Maltese: Ġiet ippreżentata dejta alternattiva sabiex turi l-bijoekwivalenza ta' Cefuroxime Alkem, Cefuroxime Krka u Cefuroxime Ingen Pharma għal prodott mediċinali ta' referenza tal-UE.
English: For cefuroxime-containing products affected by this review (Cefuroxime Alkem, Cefuroxime Krka and Cefuroxime Ingen Pharma), bioequivalence to the EU reference medicinal product was established based on an alternative bioequivalence study conducted at a different facility (study 0258-16, Lambda therapeutic Research Inc.).
Maltese: Għal prodotti li fihom cefuroxime affetwati minn din ir-reviżjoni (Cefuroxime Alkem, Cefuroxime Krka u Cefuroxime Ingen Pharma), il-bijoekwivalenza għall-prodott mediċinali ta' riferenza tal-UE kienet stabbilita abbażi ta' studju alternattiv ta' bijoekwivalenza mwettaq f'faċilità differenti (studju 0258-16, Lambda therapeutic Research Inc.).